Postoperative PainNCT04827940
The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity
A study testing Progressive relaxation exercise with music in people with Postoperative Pain and Postoperative Sleep Quality, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of progressive relaxation exercises with music therapy on sleep quality and pain severity of patients hospitalized in the surgical departments of a university hospital.This single-blind, pre-test-post-test with control group design quasi-experimental study was carried… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Sleep Quality
- What is being tested?
- Progressive relaxation exercise with music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 31 Jul 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreeing to participate in research
- Lying in surgical wards for at least a week in the range of the date of the study
- Being 18 or older
- Don't practice relaxation exercises regularly before
Who cannot join
- Not agreeing to participate in research
- Discharge before a week after admission to surgical wards within the range of the date of the study
- Those with more than a week's sleep due to the likelihood that patients may have received serious disease diagnoses that would put them off doing relaxation exercises
- Being 18 and under
- Don't be a communication problem
- Practice relaxation exercises regularly before
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Practice and Research Hospital
Eskişehir, Odunpazarı, 26040
About this study
Official title: The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity of Patients Hospitalized in Surgical Services
This study was conducted to determine the effect of progressive relaxation exercises with music therapy on sleep quality and pain severity of patients hospitalized in the surgical departments of a university hospital.This single-blind, pre-test-post-test with control group design quasi-experimental study was carried out between March-July 2019. 31 patients who were hospitalized in surgical departments for at least one week and regularly performed relaxation exercises consisted of experimental group, and 31 patients who were hospitalized for at least one week but did not do relaxation exercises consisted of control group. The study data were collected by using "Descriptive Characteristics Form", pain severity of patients was measured using "Visual Analogue Scale", and sleep quality of patients was measured using "Visual Analogue Sleep Scale". The patients were asked to perform the exercises with music an average of 30 min before sleeping every day for a week. The observation of the nurse working in department and the patient's statement were used for control. The ethical permission and the approval of hospital management were obtained for the study. In the statistical analysis of the data, independent sample t test, one-way anova and paired sample t test were used. Statistical significance level was taken as p<.05.
Read the detailed description
Inclusion criteria in the study:
- Agree to participate in research
- Staying in surgical wards for at least one week between the dates of the study
- Being 18 years or older
- Not regularly practicing relaxation exercises before
Exclusion criteria from the study:
- Refusing to participate in research
- Being discharged before one week after admission to surgical services within the range of the study date
- Those who are hospitalized for more than a week due to the possibility of serious illness diagnoses that prevent patients from performing relaxation exercises
- Being 18 years or younger
- Communication problem
- Regularly practicing previous relaxation exercises
- Conditions
- Postoperative Pain, Postoperative Sleep Quality
- Being tested
- Progressive relaxation exercise with music
- Keywords
- Pain, Postoperative, Sleep, progressive relaxation exercise, music
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercise with musicOther
The progressive relaxation technique includes exercises for the muscles in the body to consciously contract and relax together with deep breathing exercises while sitting comfortably or lying down accompanied by music.
Relaxing relaxation music for sleep, prepared by the Turkish Psychologists Association, has been installed on the mobile phones of the patients.
The patients did the relaxation exercises for an average of 30 minutes before going to bed for a week and every day with music.Relaxing relaxation music for sleep, prepared by the Turkish Psychologists Association, has been installed on the mobile phones of the patients.
The patients were taught to do the relaxation exercises for an average of 30 minutes before going to bed for a week and every day with music.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Data from the study was collected during the implementation of the "Nursing Surgical Diseases" class. Students who completed the 4-hour training program on sleep, relaxation exercises and survey practice have been pollsters of the study.
Relaxing music for sleep, prepared by the Turkish Psychological Association, is uploaded to patients' mobile phones. Patients were asked to perform relaxation exercises for a week at bedtime, lasting an average of 30 minutes, and with music every day, taking advantage of nurse observation at the clinic with the patient's declaration in check. Students who took part in the practice served as reminders of patients' compliance with the exercises. Receives: Other: Progressive relaxation exercise with music |
| Control arm | Other | Those who did not do progressive muscle relaxation exercises or did not practice regularly for a week constituted the control group. Receives: Other: Progressive relaxation exercise with music |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Incision site pain experienced after surgery
Measured: In two groups, pain intensity pre-test and post-test values were measured with Visual Analog Scale. Pre-tests were evaluated in the first hour of their arrival in the service. Post-tests were measured at 09.00 in the morning on the 7th postoperative .
postoperative sleep quality
Quality of sleep in hospital stay
Measured: In two groups, sleep quality pre-test and post-test values were measured with Visual Analog Sleep Scale. Pre-tests were applied before the surgery. Post-tests were measured at 09.00 in the morning on the 7th postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2019
- Primary completion15 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This single-blind, pre-test-post-test with control group design quasi-experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Duru, Eskisehir Osmangazi University
- Investigators
- Özlem Örsal, Dr., Study chair, ESOGUOUNedime Köşgeroğlu, Dr., Study chair, İstanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827940
- Sponsor's protocol ID
- 25403353-050.99-E.27718
- Status last verified
- Sep 2023
- First submitted
- 28 Mar 2021
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity of Patients Hospitalized in Surgical Services
- ClinicalTrials.gov ID
- NCT04827940
- Acronym / sponsor ID
- 25403353-050.99-E.27718
- Conditions
- Postoperative Pain, Postoperative Sleep Quality
- Keywords
- Pain, Postoperative, Sleep, progressive relaxation exercise, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 1 Apr 2021 (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.
This study was conducted to determine the effect of progressive relaxation exercises with music therapy on sleep quality and pain severity of patients hospitalized in the surgical departments of a university hospital.This single-blind, pre-test-post-test with control group design quasi-experimental study was carried out between March-July 2019. 31 patients who were hospitalized in surgical departments for at least one week and regularly performed relaxation exercises consisted of experimental group, and 31 patients who were hospitalized for at least one week but did not do relaxation exercises consisted of control group. The study data were collected by using "Descriptive Characteristics Form", pain severity of patients was measured using "Visual Analogue Scale", and sleep quality of patients was measured using "Visual Analogue Sleep Scale". The patients were asked to perform the exercises with music an average of 30 min before sleeping every day for a week. The observation of the nurse working in department and the patient's statement were used for control. The ethical permission and the approval of hospital management were obtained for the study. In the statistical analysis of the data, independent sample t test, one-way anova and paired sample t test were used. Statistical significance level was taken as p<.05.
Detailed description
Inclusion criteria in the study:
- Agree to participate in research
- Staying in surgical wards for at least one week between the dates of the study
- Being 18 years or older
- Not regularly practicing relaxation exercises before
Exclusion criteria from the study:
- Refusing to participate in research
- Being discharged before one week after admission to surgical services within the range of the study date
- Those who are hospitalized for more than a week due to the possibility of serious illness diagnoses that prevent patients from performing relaxation exercises
- Being 18 years or younger
- Communication problem
- Regularly practicing previous relaxation exercises
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This single-blind, pre-test-post-test with control group design quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: Progressive relaxation exercise with musicData from the study was collected during the implementation of the "Nursing Surgical Diseases" class. Students who completed the 4-hour training program on sleep, relaxation exercises and survey practice have been pollsters of the study. Relaxing music for sleep, prepared by the Turkish Psychological Association, is uploaded to patients' mobile phones. Patients were asked to perform relaxation exercises for a week at bedtime, lasting an average of 30 minutes, and with music every day, taking advantage of nurse observation at the clinic with the patient's declaration in check. Students who took part in the practice served as reminders of patients' compliance with the exercises. |
| Control arm | Other | Other: Progressive relaxation exercise with musicThose who did not do progressive muscle relaxation exercises or did not practice regularly for a week constituted the control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agreeing to participate in research
- Lying in surgical wards for at least a week in the range of the date of the study
- Being 18 or older
- Don't practice relaxation exercises regularly before
Key exclusion criteria (6 listed)
- Not agreeing to participate in research
- Discharge before a week after admission to surgical wards within the range of the date of the study
- Those with more than a week's sleep due to the likelihood that patients may have received serious disease diagnoses that would put them off doing relaxation exercises
- Being 18 and under
- Don't be a communication problem
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 |
|---|---|---|
| Progressive relaxation exercise with musicThe progressive relaxation technique includes exercises for the muscles in the body to consciously contract and relax together with deep breathing exercises while sitting comfortably or lying down accompanied by music. Relaxing relaxation music for sleep, prepared by the Turkish Psychologists Association, has been installed on the mobile phones of the patients. The patients did the relaxation exercises for an average of 30 minutes before going to bed for a week and every day with music.Relaxing relaxation music for sleep, prepared by the Turkish Psychologists Association, has been installed on the mobile phones of the patients. The patients were taught to do the relaxation exercises for an average of 30 minutes before going to bed for a week and every day with music. | Other | Control arm, intervention arm |
Primary outcome
postoperative pain
Time frame: In two groups, pain intensity pre-test and post-test values were measured with Visual Analog Scale. Pre-tests were evaluated in the first hour of their arrival in the service. Post-tests were measured at 09.00 in the morning on the 7th postoperative .
Incision site pain experienced after surgery
postoperative sleep quality
Time frame: In two groups, sleep quality pre-test and post-test values were measured with Visual Analog Sleep Scale. Pre-tests were applied before the surgery. Post-tests were measured at 09.00 in the morning on the 7th postoperative
Quality of sleep in hospital stay
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 7 Sep 2023.
- 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.
Özlem Örsal, Dr. study chair
ESOGUOU
Nedime Köşgeroğlu, Dr. study chair
İstanbul Rumeli 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 Progressive relaxation exercise with music in people with Postoperative Pain and Postoperative Sleep Quality, run by Eskisehir Osmangazi 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 4 inclusion and 6 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 7 Sep 2023. 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?
postoperative pain (time frame: In two groups, pain intensity pre-test and post-test values were measured with Visual Analog Scale. Pre-tests were evaluated in the first hour of their arrival in the service. Post-tests were measured at 09.00 in the morning on the 7th postoperative .). 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?
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 7 Sep 2023.