CystoscopyNCT04413175
Effects of Music Therapy on Procedural Pain, Anxiety and Comfort Level During Cystoscopy
A study testing music therapy in people with Cystoscopy, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Aims and objectives: This study aimed to determine the effect of music therapy on procedural pain intensity and anxiety and comfort levels in patients during cystoscopy. Background: Cystoscopy is a procedure that is commonly performed as day surgery in urology clinics in order to diagnose lower urinary tract system… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystoscopy
- What is being tested?
- music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 31 Jan 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years,
- Being literate,
- Having no hearing problems.
Who cannot join
- Patients who had allergies to anesthetic drugs
- Urinary tract infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Effects of Music Therapy on Procedural Pain, Anxiety and Comfort Level During Cystoscopy
Aims and objectives: This study aimed to determine the effect of music therapy on procedural pain intensity and anxiety and comfort levels in patients during cystoscopy.
Background: Cystoscopy is a procedure that is commonly performed as day surgery in urology clinics in order to diagnose lower urinary tract system symptoms as well as to diagnose and follow up tumors associated with the lower urinary system. During cystoscopy, which is an invasive intervention, individuals may experience pain and anxiety, and their comfort may be negatively affected.
Methods: This study was a prospective, randomized controlled trial. Study participants were randomly assigned to either a control or music group. The outcome measures were assessed using the Visual Analogue Scale, State Anxiety Scale, and General Comfort Questionnaire. This report followed the CONSORT checklist.
Read the detailed description
- INTRODUCTION Cystoscopy is a common procedure in urology clinics and has two types: flexible and rigid. Especially recently, there has been an increase in the use of flexibles. Both of these types can be preferred as a diagnostic procedure in hematuria, atypical dysuria, bladder and upper urinary tract cancers, and suspected urethral stenosis. Rigid cystoscopy can be more painful than flexible cystoscopy.
- BACKGROUND Cystoscopy is a procedure performed in urology clinics to evaluate the lower urinary tract for a large number of symptoms and pathologies, but it is painful and causes anxiety in individuals. It is recommended to perform local anesthesia to the patients during the procedure, to select appropriate cystoscopy equipment, and to make the necessary environmental arrangements in order to reduce the patients' pain and anxiety and increase their comfort levels.
Environmental arrangements to manage interventional pain in cystoscopy include music therapy that has recently been used widely.Music is used as one of the complementary therapies in the treatment of many diseases due to its physical, psychological, and functional effects on individuals. The use of music as therapy in hospitals began to become widespread with the beginning of the world wars, but the introduction of pharmacological methods for the treatment of pain and anxiety has reduced the popularity of music in this context. With the identification of side effects of drugs in the subsequent years, starting again to use music as complementary therapy has come to the fore.
Music therapy in nursing first started in the 1800s with Florence Nightingale. Nightingale described music as an effective method in the recovery process in order to provide and increase patient comfort and reduce their anxiety levels. Music therapy has also been accepted as part of nursing practices within the scope of Nursing Interventions Classification.
In the literature, international studies have been conducted to reduce the pain and anxiety levels of individuals and increase their comfort levels. Considering two systematic reviews related to the subject;some studies noted that music played during flexible cystoscopy did not reduce pain and anxiety, while some studies stated that music could be effective in reducing pain and anxiety during cystoscopy. Controversial results were found in these two studies, which have high evidence levels. Experimental studies with control groups showed that music reduced pain and anxiety and increased comfort levels in patients undergoing flexible cystoscopy. Given the limitations of the studies on the subject and sample power/deficiencies, it may be observed that controversial conclusions have been reached about the effectiveness of music in relieving pain and anxiety. On the other hand, only one study has been found in Turkey regarding this issue. In a study, the effects of various distraction methods applied during the cystoscopy procedure (group 1: music, group 2: stress ball, group 3: video, and group 4: control) on pain, anxiety, and satisfaction were examined. The study found that the patients in the video group had lower pain and anxiety levels than those in the other groups. Considering the national and international studies available in the literature, regarding the topic of music therapy that may be effective in reducing pain and anxiety during the cystoscopy procedure, it is necessary to conduct further studies that provide high levels of evidence and produce scientific knowledge with greater sample sizes and by using randomized-controlled trials that are fundamental in assessing the effectiveness of evidence-based practices. This study aimed to determine the effect of music therapy on procedural pain intensity and anxiety and comfort levels in patients during cystoscopy.
2.1. Study hypotheses Hypothesis 1. Music therapy reduces procedural pain in patients during cystoscopy.
Hypothesis 2. Music therapy reduces anxiety in patients during cystoscopy. Hypothesis 3. Music therapy increases comfort level in patients during cystoscopy.
- Conditions
- Cystoscopy
- Being tested
- music therapy
- Keywords
- Anxiety, comfort, cystoscopy, music therapy, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
Patients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure.
A portable MP3 player connected to double earphones was used in the present study. After patients took the lithotomy position for cystoscopy, their headphones were inserted and music began to be played. Music was played to the individuals for 20 minutes before and during the procedure. Headphones were removed immediately after the procedure was completed and the double earphones were cleaned with antiseptic solution after each application.
| Study group | Role | What they receive |
|---|---|---|
| a music group | Experimental | Patients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure. Receives: Other: music therapy |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: before cystoscopy
Pain scores
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: during cystoscopy procedure
Pain scores
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: immediately after cystoscopy procedure is completed
Anxiety score
Anxiety was used as the secondary outcome and measured using the Turkish version of the State-Trait Anxiety Inventory (STAI). The inventory was developed by Spielberger and colleagues and tested for its validity and reliability in Turkish by Öner and Le Compte. Its internal consistency, test-retest reliability, and item-by-item reliability values were found to be between 0.83 and 0.87, 0.71 and 0.86, and 0.34 and 0.72, respectively. The STAI consists of a State Anxiety Scale (STAI-S) and a Trait Anxiety Scale (STAI-T). Only the STAI-S was used in this study. The lowest total score that can be obtained from the scale is 20, and the highest total score is 80. A high score indicates high anxiety level, and a low score indicates low anxiety level
Measured: before cystoscopy
Anxiety score
Anxiety was used as the secondary outcome and measured using the Turkish version of the State-Trait Anxiety Inventory (STAI). The inventory was developed by Spielberger and colleagues and tested for its validity and reliability in Turkish by Öner and Le Compte. Its internal consistency, test-retest reliability, and item-by-item reliability values were found to be between 0.83 and 0.87, 0.71 and 0.86, and 0.34 and 0.72, respectively. The STAI consists of a State Anxiety Scale (STAI-S) and a Trait Anxiety Scale (STAI-T). Only the STAI-S was used in this study. The lowest total score that can be obtained from the scale is 20, and the highest total score is 80. A high score indicates high anxiety level, and a low score indicates low anxiety level
Measured: immediately after cystoscopy procedure is completed
Comfort scores
The third outcome was comfort, which was measured using the General Comfort Questionnaire (GCQ). This questionnaire was developed by Katharine Kolcaba to determine individuals' comfort needs and evaluate nursing interventions that may be employed to ensure and increase such comfort. The GCQ uses a four-point Likert-type scale and consists of 48 items. The lowest score that can be obtained when using the scale is 48, and the highest score is 192. The GCQ was adapted for use in a Turkish context by Kuğuoğlu and Karabacak.
Measured: before cystoscopy
Comfort scores
The third outcome was comfort, which was measured using the General Comfort Questionnaire (GCQ). This questionnaire was developed by Katharine Kolcaba to determine individuals' comfort needs and evaluate nursing interventions that may be employed to ensure and increase such comfort. The GCQ uses a four-point Likert-type scale and consists of 48 items. The lowest score that can be obtained when using the scale is 48, and the highest score is 192. The GCQ was adapted for use in a Turkish context by Kuğuoğlu and Karabacak.
Measured: immediately after cystoscopy procedure is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Apr 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanife DURGUN, Ordu University
- Investigators
- Hanife Durgun, Dr, Principal investigator, Ordu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413175
- Sponsor's protocol ID
- HanifeD
- Status last verified
- Jun 2020
- First submitted
- 18 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effects of Music Therapy on Procedural Pain, Anxiety and Comfort Level During Cystoscopy
- ClinicalTrials.gov ID
- NCT04413175
- Acronym / sponsor ID
- HanifeD
- Conditions
- Cystoscopy
- Keywords
- Anxiety, comfort, cystoscopy, music therapy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 2 Jun 2020 (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.
Aims and objectives: This study aimed to determine the effect of music therapy on procedural pain intensity and anxiety and comfort levels in patients during cystoscopy.
Background: Cystoscopy is a procedure that is commonly performed as day surgery in urology clinics in order to diagnose lower urinary tract system symptoms as well as to diagnose and follow up tumors associated with the lower urinary system. During cystoscopy, which is an invasive intervention, individuals may experience pain and anxiety, and their comfort may be negatively affected.
Methods: This study was a prospective, randomized controlled trial. Study participants were randomly assigned to either a control or music group. The outcome measures were assessed using the Visual Analogue Scale, State Anxiety Scale, and General Comfort Questionnaire. This report followed the CONSORT checklist.
Detailed description
- INTRODUCTION Cystoscopy is a common procedure in urology clinics and has two types: flexible and rigid. Especially recently, there has been an increase in the use of flexibles. Both of these types can be preferred as a diagnostic procedure in hematuria, atypical dysuria, bladder and upper urinary tract cancers, and suspected urethral stenosis. Rigid cystoscopy can be more painful than flexible cystoscopy.
- BACKGROUND Cystoscopy is a procedure performed in urology clinics to evaluate the lower urinary tract for a large number of symptoms and pathologies, but it is painful and causes anxiety in individuals. It is recommended to perform local anesthesia to the patients during the procedure, to select appropriate cystoscopy equipment, and to make the necessary environmental arrangements in order to reduce the patients' pain and anxiety and increase their comfort levels.
Environmental arrangements to manage interventional pain in cystoscopy include music therapy that has recently been used widely.Music is used as one of the complementary therapies in the treatment of many diseases due to its physical, psychological, and functional effects on individuals. The use of music as therapy in hospitals began to become widespread with the beginning of the world wars, but the introduction of pharmacological methods for the treatment of pain and anxiety has reduced the popularity of music in this context. With the identification of side effects of drugs in the subsequent years, starting again to use music as complementary therapy has come to the fore.
Music therapy in nursing first started in the 1800s with Florence Nightingale. Nightingale described music as an effective method in the recovery process in order to provide and increase patient comfort and reduce their anxiety levels. Music therapy has also been accepted as part of nursing practices within the scope of Nursing Interventions Classification.
In the literature, international studies have been conducted to reduce the pain and anxiety levels of individuals and increase their comfort levels. Considering two systematic reviews related to the subject;some studies noted that music played during flexible cystoscopy did not reduce pain and anxiety, while some studies stated that music could be effective in reducing pain and anxiety during cystoscopy. Controversial results were found in these two studies, which have high evidence levels. Experimental studies with control groups showed that music reduced pain and anxiety and increased comfort levels in patients undergoing flexible cystoscopy. Given the limitations of the studies on the subject and sample power/deficiencies, it may be observed that controversial conclusions have been reached about the effectiveness of music in relieving pain and anxiety. On the other hand, only one study has been found in Turkey regarding this issue. In a study, the effects of various distraction methods applied during the cystoscopy procedure (group 1: music, group 2: stress ball, group 3: video, and group 4: control) on pain, anxiety, and satisfaction were examined. The study found that the patients in the video group had lower pain and anxiety levels than those in the other groups. Considering the national and international studies available in the literature, regarding the topic of music therapy that may be effective in reducing pain and anxiety during the cystoscopy procedure, it is necessary to conduct further studies that provide high levels of evidence and produce scientific knowledge with greater sample sizes and by using randomized-controlled trials that are fundamental in assessing the effectiveness of evidence-based practices. This study aimed to determine the effect of music therapy on procedural pain intensity and anxiety and comfort levels in patients during cystoscopy.
2.1. Study hypotheses Hypothesis 1. Music therapy reduces procedural pain in patients during cystoscopy.
Hypothesis 2. Music therapy reduces anxiety in patients during cystoscopy. Hypothesis 3. Music therapy increases comfort level in patients during cystoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a music group | Experimental | Other: music therapyPatients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure. |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years,
- Being literate,
- Having no hearing problems.
Key exclusion criteria (2 listed)
- Patients who had allergies to anesthetic drugs
- Urinary tract infection.
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 |
|---|---|---|
| music therapyPatients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure. A portable MP3 player connected to double earphones was used in the present study. After patients took the lithotomy position for cystoscopy, their headphones were inserted and music began to be played. Music was played to the individuals for 20 minutes before and during the procedure. Headphones were removed immediately after the procedure was completed and the double earphones were cleaned with antiseptic solution after each application. | Other | a music group |
Primary outcome
Pain scores
Time frame: before cystoscopy
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain scores
Time frame: during cystoscopy procedure
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain scores
Time frame: immediately after cystoscopy procedure is completed
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Anxiety score
Time frame: before cystoscopy
Anxiety was used as the secondary outcome and measured using the Turkish version of the State-Trait Anxiety Inventory (STAI). The inventory was developed by Spielberger and colleagues and tested for its validity and reliability in Turkish by Öner and Le Compte. Its internal consistency, test-retest reliability, and item-by-item reliability values were found to be between 0.83 and 0.87, 0.71 and 0.86, and 0.34 and 0.72, respectively. The STAI consists of a State Anxiety Scale (STAI-S) and a Trait Anxiety Scale (STAI-T). Only the STAI-S was used in this study. The lowest total score that can be obtained from the scale is 20, and the highest total score is 80. A high score indicates high anxiety level, and a low score indicates low anxiety level
Anxiety score
Time frame: immediately after cystoscopy procedure is completed
Anxiety was used as the secondary outcome and measured using the Turkish version of the State-Trait Anxiety Inventory (STAI). The inventory was developed by Spielberger and colleagues and tested for its validity and reliability in Turkish by Öner and Le Compte. Its internal consistency, test-retest reliability, and item-by-item reliability values were found to be between 0.83 and 0.87, 0.71 and 0.86, and 0.34 and 0.72, respectively. The STAI consists of a State Anxiety Scale (STAI-S) and a Trait Anxiety Scale (STAI-T). Only the STAI-S was used in this study. The lowest total score that can be obtained from the scale is 20, and the highest total score is 80. A high score indicates high anxiety level, and a low score indicates low anxiety level
Comfort scores
Time frame: before cystoscopy
The third outcome was comfort, which was measured using the General Comfort Questionnaire (GCQ). This questionnaire was developed by Katharine Kolcaba to determine individuals' comfort needs and evaluate nursing interventions that may be employed to ensure and increase such comfort. The GCQ uses a four-point Likert-type scale and consists of 48 items. The lowest score that can be obtained when using the scale is 48, and the highest score is 192. The GCQ was adapted for use in a Turkish context by Kuğuoğlu and Karabacak.
Comfort scores
Time frame: immediately after cystoscopy procedure is completed
The third outcome was comfort, which was measured using the General Comfort Questionnaire (GCQ). This questionnaire was developed by Katharine Kolcaba to determine individuals' comfort needs and evaluate nursing interventions that may be employed to ensure and increase such comfort. The GCQ uses a four-point Likert-type scale and consists of 48 items. The lowest score that can be obtained when using the scale is 48, and the highest score is 192. The GCQ was adapted for use in a Turkish context by Kuğuoğlu and Karabacak.
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 2 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Cystoscopy
RecruitingPhase 3
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Bladder Cancer
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
RecruitingObservational study
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)
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.
Hanife Durgun, Dr principal investigator
Ordu State Hospital
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 in people with Cystoscopy, run by Ordu University 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 3 inclusion and 2 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 2 Jun 2020. 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 scores (time frame: before cystoscopy). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2020.