- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06726239
Progressive Relaxation Exercises Before Mobilization:Effects on Pain, Anxiety and Physiologic Parameters CABG Patients
The Effect of Progressive Relaxation Exercises Applied Before Mobilization on Pain, Anxiety and Physiological Parameters in Patients With Coronary Artery Bypass Graft Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuğçe Bozkurt
- Phone Number: 05063137927
- Email: tgcebzkrt55@gmail.com
Study Contact Backup
- Name: Ayfer Özbaş
- Phone Number: 05063137927
- Email: tgcebzkrt55@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34320
- Recruiting
- Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
-
Contact:
- Tuğçe Bozkurt
- Phone Number: 05063137927
- Email: tgcebzkurtt@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to read and write in Turkish,
- Analgesics given ≥4h before assessment,
- Conscious and communicative,
- Elective coronary artery bypass graft surgery planned,
- Patients undergoing coronary artery bypass graft surgery for the first time were included in the study.
Exclusion Criteria:
- Diagnosed with a psychiatric or neurological disorder,
- Diagnosis of a musculoskeletal condition that could affect mobilization,
- Patients with hearing and vision loss,
- Patients participating in another clinical trial during the same period,
- Patients who developed any complications during the postoperative period were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention
In the preoperative period, patients in the control group completed the Patient Demographic Information Form and the Trait Anxiety Inventory.
Patients were preoperatively informed about wearing a smart bracelet on postoperative days 1 and 2 to track step count and walking distance.
Physiological parameters, state anxiety, and pain levels (Short-Form McGill Pain Questionnaire) were evaluated at pre-test, 30 minutes later, and 15 minutes after mobilization.
Additionally, pain intensity was assessed immediately after mobilization.
On postoperative days 1 and 2, all assessments were conducted twice daily.
The frequency of analgesic administration was also monitored.
|
|
|
Experimental: Experimental
In the preoperative period, patients completed the Patient Demographic Information Form and the Trait Anxiety Inventory. Patients were preoperatively informed about wearing a smart bracelet on postoperative days 1 and 2 to track step count and walking distance. Furthermore, patients in the intervention group received video-assisted training on diaphragmatic breathing and progressive muscle relaxation (PMR) exercises. In the intervention group, PMR was performed twice a day on postoperative days 1 and 2. Physiological parameters, state anxiety, and pain levels (Short-Form McGill Pain Questionnaire) were measured at pre-test, 5 minutes after each PMR session, and 15 minutes after mobilization. Additionally, pain intensity was assessed immediately after mobilization. The frequency of analgesic administration was also monitored. |
The aim of relaxation exercises is to help individuals recognize the difference between tension and relaxation and to enable them to relax in situations of stress.
These exercises are performed with light background music and verbal instructions, allowing patients to mentally focus on the process.
The progressive relaxation technique involves the voluntary contraction and subsequent relaxation of muscle groups, typically starting from the hands and progressing to the feet, with each muscle group activated in sequence.
During the exercise, the instructions and steps from the 'Relaxation Exercises' CD published by the Turkish Psychologists Association will be followed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trait Anxiety Inventory
Time Frame: Preoperative
|
The Trait Anxiety Inventory is used to determine how the individual "usually" feels and the items of the scale are scored between 1-4 points (1=almost never, 2=sometimes, 3=very often, 4=almost always).
There are 7 reversed statements in the trait anxiety subscale (items 21, 26, 27, 30, 33, 36 and 39).
|
Preoperative
|
|
Descriptive Characteristics Form
Time Frame: Preoperative
|
The first part includes questions about demographic characteristics such as gender, age, body mass index (height-weight), marital status, education level, income level and occupation, and the second part includes questions about other chronic diseases, previous surgery, previous stay in the intensive care unit, smoking and alcohol use.
|
Preoperative
|
|
Physiological parameters monitoring
Time Frame: Postoperative Day 1:(measured twice, 6-hour apart): Control: Pre-test, 30 min later, 15 min post-mobilization Experimental: Pre-test, 5 min post-PGE, 15 min post-mobilization. Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
|
Physiological parameters will be monitored.
|
Postoperative Day 1:(measured twice, 6-hour apart): Control: Pre-test, 30 min later, 15 min post-mobilization Experimental: Pre-test, 5 min post-PGE, 15 min post-mobilization. Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
|
|
State Anxiety Inventory
Time Frame: Postop Day 1:(measured twice, 6-hour apart): Control: Pre-test,30 minutes after,15 min post-mobilization.Experimental: Pre-test, 5 minutes after PGE, 15 min post-mobilization.Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
|
It is used to determine how the individual feels "right now" and the items of the scale are scored between 1-4 points (1=not at all, 2=somewhat, 3=very much, 4=completely).
|
Postop Day 1:(measured twice, 6-hour apart): Control: Pre-test,30 minutes after,15 min post-mobilization.Experimental: Pre-test, 5 minutes after PGE, 15 min post-mobilization.Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
|
|
Short Form McGill Pain Questionnaire
Time Frame: Postop1:Measured twice at 6h:Control:Pre-test, 30 min later, post-mobilization vas, 15 min post-mobilization. Experimental: Pre-test, 5 min post-PGE, post-mobilization vas, 15 min post-mobilization.Postop2: Both groups:Measured twice at 6-hour intervals
|
The scale consists of three parts in which the nature of pain, intensity of pain and overall pain intensity are evaluated.
|
Postop1:Measured twice at 6h:Control:Pre-test, 30 min later, post-mobilization vas, 15 min post-mobilization. Experimental: Pre-test, 5 min post-PGE, post-mobilization vas, 15 min post-mobilization.Postop2: Both groups:Measured twice at 6-hour intervals
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analgesia monitoring form
Time Frame: Postoperative day 1 and 2
|
In this form prepared by the researcher in line with the literature, the name, dose, time and route of administration will be recorded in case of analgesic use of the patients.
|
Postoperative day 1 and 2
|
|
Mobilization Schedule
Time Frame: Postoperative day 1 and 2
|
Mobilization will be assessed on postoperative days 1 and 2 based on the number of steps taken, distance covered, and relevant features of the mobilization process.
|
Postoperative day 1 and 2
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
Clinical Trials on Progressive relaxation exercises
-
Ataturk UniversityCompletedStress | Anxiety | Nursing Students | Relaxation ProgramTurkey
-
Karamanoğlu Mehmetbey UniversityNot yet recruitingCircadian Rhythm | Nursing | Symptom Management | Hemodialysis Patient | Relaxation Exercise
-
Aydin Adnan Menderes UniversityUludag UniversityCompletedMenopause | Menopause Related ConditionsTurkey (Türkiye)
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Izmir Bakircay UniversityCompletedCopd | Dyspnea | Nursing CariesTurkey
-
Kutahya Health Sciences UniversityCompletedThe Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal PeriodFatigue | Sleep Quality | Postmenopausal PeriodTurkey
-
Nigde Omer Halisdemir UniversityTC Erciyes UniversityCompletedAnxiety | Dyspnea
-
Kutahya Health Sciences UniversityCompletedPremenstrual SyndromeTurkey
-
University of GaziantepNot yet recruiting
-
Erzincan Binali Yildirim UniversitesiNot yet recruitingAnxiety | Total Knee Replacement Surgery | Exercises TherapyTurkey