NCT06726239

Brief Summary

This study is planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises applied before mobilization on pain, anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

December 2, 2024

Last Update Submit

June 26, 2025

Conditions

Keywords

coronary artery bypass graft surgerypainAnxietyprogressive relaxation exercisephysiological parameter

Outcome Measures

Primary Outcomes (5)

  • Descriptive Characteristics Form

    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

  • Trait Anxiety Inventory

    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

  • Physiological parameters monitoring

    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

    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

    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 Outcomes (2)

  • Mobilization Schedule

    Postoperative day 1 and 2

  • Analgesia monitoring form

    Postoperative day 1 and 2

Study Arms (2)

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.

Other: Progressive relaxation exercises

Interventions

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.

Experimental

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Istanbul, Istanbul, 34320, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: experiment-control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate in Surgical Nursing, Istanbul University-Cerrahpasa

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 10, 2024

Study Start

May 31, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the ethical approval for the study and the informed consent obtained from participants do not include permission to share data with third parties. Additionally, the responsibility to protect participant privacy and data confidentiality prevents such sharing.

Locations