PainNCT06649617
The Effect of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety
A study testing Music Therapy Group and Virtual Reality Group in people with Pain and Anxiety, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
Background and Aim: Invasive procedures such as intravenous , intramuscular and subcutaneous Injection practices are among the most frequently performed nursing interventions in ıntensive care units. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Physiological Parameter
- What is being tested?
- Music Therapy Group and Virtual Reality Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2022to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients;
- must be over 18 years old,
- have no visual or hearing impairment,
- have stable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation, pain),
- be not intubated,
- be willing to participate in the study.
Who cannot join
- Patients;
- have visual and hearing impairment,
- have unstable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation, pain),
- are intubated,
- do not volunteer for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety in Nursing Interventions Applied to Intensive Care Patients: A Randomized Controlled Experimental Study
Background and Aim: Invasive procedures such as intravenous , intramuscular and subcutaneous Injection practices are among the most frequently performed nursing interventions in ıntensive care units. However, although nursing interventions positively affect the clinical results of the patient, they can cause anxiety and pain. In recent years, music therapy and virtual reality, which are nonpharmacological methods, have been widely used in reducing pain and anxiety. Based on this information, this study was conducted as a randomized controlled experimental to evaluate the effects of virtual reality and music therapy on physiological parameters and anxiety in nursing ınterventions applied to ıntensive care patients.
Methods:The research was conducted with 90 patient in intensive care unit. The patients in the sample group were randomly determined by the researcher as Control Group (Standard Procedure), Music Therapy Group and Virtual Reality Group. The selection of patients included in the study was made using a random number table. Research data were collected using a structured patient information form, VAS pain scale , and state and trait anxiety inventory.The data were analyzed using SPSS 25 program.
Keywords: music therapy, virtual reality, nursing interventions, intensive care
Read the detailed description
This study was conducted as a Randomized Controlled Experimental to evaluate the Effects of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety in Nursing Interventions Applied to Intensive Care Patients.
Hypotheses of the Research; H1 1 : Virtual Reality and Music Therapy Improve Physiological Parameters in Nursing Interventions Applied to Intensive Care Patients.
H1 2 : Virtual Reality and Music Therapy in Nursing Interventions Applied to Intensive Care Patients reduces pain.
H1 3 : Virtual Reality and Music Therapy reduce anxiety in Nursing Interventions Applied to Intensive Care Patients .
Variables of the Research; The independent variables of the study are music therapy , virtual reality technology and standard procedure (explanation of the nursing intervention to the patient before the procedure).
The dependent variables of the study are the physiological parameters (pulse, blood pressure, fever, pain) and anxiety levels of the patients during nursing interventions.
The intensive care unit of a foundation university hospital between May 2022 and July 2022. In order to determine the number of patients constituting the research sample, a similar study (13) was taken as an example in the relevant literature and the power analysis G* Power 3.1 software was used. In this study, the sample size was calculated as 84, with 28 participants in each group, to reach a power level of 95% at a 0.5 effect size and 5% error level. Considering the high power of the test and the losses in the study , a total of 90 people were reached, 30 in each group. The patients in the sample group were randomly determined by the researcher as Control Group (Standard Procedure), Music Therapy Group and Virtual Reality Group. The selection of patients included in the study was made using a random number table. The randomization table was created by using the website http://stattrek.com/statistics/random-number-generator.aspx for randomization . As a result, the sample of the study consisted of 90 patients in total, 30 participants in each patient group, who were informed after the purpose of the study was explained and permission was obtained to participate in the study and who met the sample criteria of the study. The sample criteria were; the patient was over 18 years of age, had no visual or hearing impairment, had stable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation , pain), was not intubated and volunteered for the study.Research data were collected using a structured patient information form, VAS pain scale , and state and trait anxiety inventory.application, the 3 groups of the study (control, virtual reality, music therapy ) were randomly assigned to 3 halls of the intensive care unit . Thus, the application was performed on one group of patients in one hall. All patients participating in the study filled out the "Structured Patient Information Form". Then, the patients were divided into 3 groups. The standard procedure (verbal procedure explanation) was applied to the control group patients. The virtual reality group patients were shown 3-dimensional videos with a relaxation effect using virtual glasses. The music therapy group patients were made to listen to the Büzürk makam , a Turkish musical makam . In this study, while nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) were applied to all 3 groups of patients, the physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain and anxiety levels of the patients were evaluated before and after the procedure .
Application in Control Group: Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. After all the applications were completed, virtual glasses or music therapy was applied to the volunteers from the control group in order to ensure the principle of equality, which is one of the ethical principles .
Application in Music Therapy Group: Before the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed.
Application in Virtual Reality Group: Before the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed.
Ethical considerations Before starting the research, permission was obtained from the Istanbul Beykent University Social and Human Sciences Scientific Research and Publication Ethics Board with the decision number 223 dated 09.05.2022. Written permission was obtained from the institution where the research was conducted. After the information about the research, the patients who agreed to participate voluntarily were asked to read and sign the consent forms prepared for each group. The researcher, who completed the application phase of the research, is a faculty member in the Department of Nursing Fundamentals.
Data analysis The data obtained in the study were obtained using SPSS (Statistical Package for Social Sciences ) for Windows 25.0 program was used for analysis. Descriptive statistical methods were used for data evaluation as number, percentage, mean, standard deviation. Differences between proportions of categorical variables in independent groups were analyzed using Chi-Square and Fisher It was analyzed with exact tests. T-test was used to compare quantitative continuous data between two independent groups. Dependent groups t-test was used to compare within-group measurements.
- Conditions
- Pain, Anxiety, Physiological Parameter
- Being tested
- Control Group (Standard Procedure), Music Therapy Group, Virtual Reality Group
- Keywords
- pain, anxiety, physiological parameter, intensive care, nursing interventions,, music threapy, virtual reality
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group (Standard Procedure)Other
Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. .
Music Therapy GroupOther
Before the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed.
Virtual Reality GroupOther
Before the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Procedure) | Experimental | Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. Receives: Other: Control Group (Standard Procedure) |
| Music Therapy Group | Experimental | Before the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed. Receives: Other: Music Therapy Group |
| Virtual Reality Group | Experimental | Before the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed. Receives: Other: Virtual Reality Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Patients were informed about the Visual Analogue Scale. Visual Analogue Scale: The level of pain, which is one of the physiological parameters, will be evaluated with the VAS pain scale . The scale includes facial expressions that show the level of pain between 0 and 10.
Measured: 2 month
physiological parameter values (pulse rate /minute, respiratory rate/minute, systolic and diastolic blood pressure mm/Hg, oxygen saturation %, body temperature oC)
patients were informed about physiological parameters. Physiological parameter values (ulse rate /minute, respiratory rate/minute, systolic and diastolic blood pressure mm/Hg, oxygen saturation %, body temperature oC)
Measured: 2 month
Secondary outcomes (1)
Anxiety level
Patients were informed about the State-Trait Anxiety Inventory
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start9 May 2022
- Primary completion9 Jun 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamiyet KIZIL, University of Beykent
- Investigators
- Hamiyet Kızıl, Phd RN, Principal investigator, Istanbul Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649617
- Sponsor's protocol ID
- 223
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamdan KM, Shaheen AM, Abdalrahim MS. Barriers and enablers of intensive care unit nurses' assessment and management of patients' pain. Nurs Crit Care. 2022 Jul;27(4):567-575. doi: 10.1111/nicc.12624. Epub 2021 Apr 1.
PubMed 33797160Golino AJ, Leone R, Gollenberg A, Gillam A, Toone K, Samahon Y, Davis TM, Stanger D, Friesen MA, Meadows A. Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit. Am J Crit Care. 2023 Mar 1;32(2):109-115. doi: 10.4037/ajcc2023499.
PubMed 36854910Koticha P, Katge F, Shetty S, Patil DP. Effectiveness of Virtual Reality Eyeglasses as a Distraction Aid to Reduce Anxiety among 6-10-year-old Children Undergoing Dental Extraction Procedure. Int J Clin Pediatr Dent. 2019 Jul-Aug;12(4):297-302. doi: 10.5005/jp-journals-10005-1640.
PubMed 31866714
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety in Nursing Interventions Applied to Intensive Care Patients: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT06649617
- Acronym / sponsor ID
- 223
- Conditions
- Pain, Anxiety, Physiological Parameter
- Keywords
- pain, anxiety, physiological parameter, intensive care, nursing interventions,, music threapy, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Aim: Invasive procedures such as intravenous , intramuscular and subcutaneous Injection practices are among the most frequently performed nursing interventions in ıntensive care units. However, although nursing interventions positively affect the clinical results of the patient, they can cause anxiety and pain. In recent years, music therapy and virtual reality, which are nonpharmacological methods, have been widely used in reducing pain and anxiety. Based on this information, this study was conducted as a randomized controlled experimental to evaluate the effects of virtual reality and music therapy on physiological parameters and anxiety in nursing ınterventions applied to ıntensive care patients.
Methods:The research was conducted with 90 patient in intensive care unit. The patients in the sample group were randomly determined by the researcher as Control Group (Standard Procedure), Music Therapy Group and Virtual Reality Group. The selection of patients included in the study was made using a random number table. Research data were collected using a structured patient information form, VAS pain scale , and state and trait anxiety inventory.The data were analyzed using SPSS 25 program.
Keywords: music therapy, virtual reality, nursing interventions, intensive care
Detailed description
This study was conducted as a Randomized Controlled Experimental to evaluate the Effects of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety in Nursing Interventions Applied to Intensive Care Patients.
Hypotheses of the Research; H1 1 : Virtual Reality and Music Therapy Improve Physiological Parameters in Nursing Interventions Applied to Intensive Care Patients.
H1 2 : Virtual Reality and Music Therapy in Nursing Interventions Applied to Intensive Care Patients reduces pain.
H1 3 : Virtual Reality and Music Therapy reduce anxiety in Nursing Interventions Applied to Intensive Care Patients .
Variables of the Research; The independent variables of the study are music therapy , virtual reality technology and standard procedure (explanation of the nursing intervention to the patient before the procedure).
The dependent variables of the study are the physiological parameters (pulse, blood pressure, fever, pain) and anxiety levels of the patients during nursing interventions.
The intensive care unit of a foundation university hospital between May 2022 and July 2022. In order to determine the number of patients constituting the research sample, a similar study (13) was taken as an example in the relevant literature and the power analysis G* Power 3.1 software was used. In this study, the sample size was calculated as 84, with 28 participants in each group, to reach a power level of 95% at a 0.5 effect size and 5% error level. Considering the high power of the test and the losses in the study , a total of 90 people were reached, 30 in each group. The patients in the sample group were randomly determined by the researcher as Control Group (Standard Procedure), Music Therapy Group and Virtual Reality Group. The selection of patients included in the study was made using a random number table. The randomization table was created by using the website http://stattrek.com/statistics/random-number-generator.aspx for randomization . As a result, the sample of the study consisted of 90 patients in total, 30 participants in each patient group, who were informed after the purpose of the study was explained and permission was obtained to participate in the study and who met the sample criteria of the study. The sample criteria were; the patient was over 18 years of age, had no visual or hearing impairment, had stable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation , pain), was not intubated and volunteered for the study.Research data were collected using a structured patient information form, VAS pain scale , and state and trait anxiety inventory.application, the 3 groups of the study (control, virtual reality, music therapy ) were randomly assigned to 3 halls of the intensive care unit . Thus, the application was performed on one group of patients in one hall. All patients participating in the study filled out the "Structured Patient Information Form". Then, the patients were divided into 3 groups. The standard procedure (verbal procedure explanation) was applied to the control group patients. The virtual reality group patients were shown 3-dimensional videos with a relaxation effect using virtual glasses. The music therapy group patients were made to listen to the Büzürk makam , a Turkish musical makam . In this study, while nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) were applied to all 3 groups of patients, the physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain and anxiety levels of the patients were evaluated before and after the procedure .
Application in Control Group: Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. After all the applications were completed, virtual glasses or music therapy was applied to the volunteers from the control group in order to ensure the principle of equality, which is one of the ethical principles .
Application in Music Therapy Group: Before the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed.
Application in Virtual Reality Group: Before the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed.
Ethical considerations Before starting the research, permission was obtained from the Istanbul Beykent University Social and Human Sciences Scientific Research and Publication Ethics Board with the decision number 223 dated 09.05.2022. Written permission was obtained from the institution where the research was conducted. After the information about the research, the patients who agreed to participate voluntarily were asked to read and sign the consent forms prepared for each group. The researcher, who completed the application phase of the research, is a faculty member in the Department of Nursing Fundamentals.
Data analysis The data obtained in the study were obtained using SPSS (Statistical Package for Social Sciences ) for Windows 25.0 program was used for analysis. Descriptive statistical methods were used for data evaluation as number, percentage, mean, standard deviation. Differences between proportions of categorical variables in independent groups were analyzed using Chi-Square and Fisher It was analyzed with exact tests. T-test was used to compare quantitative continuous data between two independent groups. Dependent groups t-test was used to compare within-group measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Procedure) | Experimental | Other: Control Group (Standard Procedure)Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. |
| Music Therapy Group | Experimental | Other: Music Therapy GroupBefore the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed. |
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupBefore the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients;
- must be over 18 years old,
- have no visual or hearing impairment,
- have stable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation, pain),
- be not intubated,
Key exclusion criteria (5 listed)
- Patients;
- have visual and hearing impairment,
- have unstable hemodynamic and physiological parameters (pulse, respiration, blood pressure, oxygen saturation, pain),
- are intubated,
- do not volunteer for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Group (Standard Procedure)Before the application of nursing interventions ( Intramuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Then , information was given about the nursing intervention to be performed as a standard procedure . The nursing intervention was applied. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary for the patients ( Intramuscular , Intravenous , Subcutaneous Injection), that application was applied. No unnecessary procedure was applied. . | Other | Control Group (Standard Procedure) |
| Music Therapy GroupBefore the application of nursing interventions ( intramuscular , intravenous , subcutaneous injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients were made to listen to Büzürk makam, a Turkish musical makam. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( intramuscular , intravenous , subcutaneous injection), that application was performed on the patients . No unnecessary procedure was performed. | Other | Music Therapy Group |
| Virtual Reality GroupBefore the application of nursing interventions ( Intamuscular , Intravenous , Subcutaneous Injection) to the patients, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. During the nursing intervention, the patients watched 3D videos with relaxation effect with virtual glasses. After the application, the patients' physiological parameters (fever, pulse, blood pressure, respiration and oxygen saturation ), pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated. Whichever nursing intervention was necessary ( Intamuscular , Intravenous , Subcutaneous Injection), that application was performed on the patients . No unnecessary procedure was performed. | Other | Virtual Reality Group |
Primary outcome
Pain severity
Time frame: 2 month
Patients were informed about the Visual Analogue Scale. Visual Analogue Scale: The level of pain, which is one of the physiological parameters, will be evaluated with the VAS pain scale . The scale includes facial expressions that show the level of pain between 0 and 10.
physiological parameter values (pulse rate /minute, respiratory rate/minute, systolic and diastolic blood pressure mm/Hg, oxygen saturation %, body temperature oC)
Time frame: 2 month
patients were informed about physiological parameters. Physiological parameter values (ulse rate /minute, respiratory rate/minute, systolic and diastolic blood pressure mm/Hg, oxygen saturation %, body temperature oC)
1 secondary outcome
Anxiety level
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Background: PubMed 33797160Hamdan KM, Shaheen AM, Abdalrahim MS. Barriers and enablers of intensive care unit nurses' assessment and management of patients' pain. Nurs Crit Care. 2022 Jul;27(4):567-575. doi: 10.1111/nicc.12624. Epub 2021 Apr 1.
- Results publication: PubMed 36854910Golino AJ, Leone R, Gollenberg A, Gillam A, Toone K, Samahon Y, Davis TM, Stanger D, Friesen MA, Meadows A. Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit. Am J Crit Care. 2023 Mar 1;32(2):109-115. doi: 10.4037/ajcc2023499.
- Results publication: PubMed 31866714Koticha P, Katge F, Shetty S, Patil DP. Effectiveness of Virtual Reality Eyeglasses as a Distraction Aid to Reduce Anxiety among 6-10-year-old Children Undergoing Dental Extraction Procedure. Int J Clin Pediatr Dent. 2019 Jul-Aug;12(4):297-302. doi: 10.5005/jp-journals-10005-1640.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamiyet Kızıl, Phd RN principal investigator
Istanbul Beykent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy Group and Virtual Reality Group in people with Pain and Anxiety, run by University of Beykent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06649617, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.