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The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity

Primary Purpose

Postoperative Pain, Postoperative Sleep Quality

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive relaxation exercise with music
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring Pain, Postoperative, Sleep, progressive relaxation exercise, music

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Eskişehir Osmangazi University Practice and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

intervention arm

Control arm

Arm Description

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.

Those who did not do progressive muscle relaxation exercises or did not practice regularly for a week constituted the control group.

Outcomes

Primary Outcome Measures

postoperative pain
Incision site pain experienced after surgery
postoperative sleep quality
Quality of sleep in hospital stay

Secondary Outcome Measures

Full Information

First Posted
March 28, 2021
Last Updated
September 5, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04827940
Brief Title
The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity
Official Title
The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity of Patients Hospitalized in Surgical Services
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Sleep Quality
Keywords
Pain, Postoperative, Sleep, progressive relaxation exercise, music

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This single-blind, pre-test-post-test with control group design quasi-experimental study
Masking
Participant
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
Those who did not do progressive muscle relaxation exercises or did not practice regularly for a week constituted the control group.
Intervention Type
Other
Intervention Name(s)
Progressive relaxation exercise with music
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
Incision site pain experienced after surgery
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 .
Title
postoperative sleep quality
Description
Quality of sleep in hospital stay
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özlem Örsal, Dr.
Organizational Affiliation
ESOGUOU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nedime Köşgeroğlu, Dr.
Organizational Affiliation
İstanbul Rumeli University
Official's Role
Study Chair
Facility Information:
Facility Name
Eskişehir Osmangazi University Practice and Research Hospital
City
Eskişehir
State/Province
Odunpazarı
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain Intensity

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