NCT06524999

Brief Summary

This study aimed to examine the effect of relaxation exercise applied to patients who will undergo elective coronary angiography (CAG) for the first time, on their vital signs, anxiety and comfort levels. The main questions it aims to answer are:

  1. 1.Does progressive relaxation exercises affect CAG patients' vital signs.
  2. 2.Does progressive relaxation exercises affect CAG patients' anxiety levels.
  3. 3.Does progressive relaxation exercises affect CAG patients' comfort levels. Researchers will compare the intervention group with the control group to see if relaxation exercise is effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 24, 2025

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

July 19, 2024

Last Update Submit

July 21, 2025

Conditions

Keywords

Anxietycoronary angiographypatient comfortprogressive relaxation exercisevital signs

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Scale

    The State Anxiety Scale (SAS) shows how an individual feels under certain circumstances at certain times. It consists of 20 items rated on a four-point Likert-type scale ("1: none" to "4: all"). The total score ranges from 20 to 80, with higher scores indicating more anxiety.

    First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

Secondary Outcomes (7)

  • The General Comfort Scale Short Form

    First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

  • The Vital Signs Follow-up (for blood pressure)

    First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

  • The Vital Signs Follow-up (for pulse)

    First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

  • The Vital Signs Follow-up (for respiration)

    First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

  • The Vital Signs Follow-up (saturation)

    First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

  • +2 more secondary outcomes

Study Arms (2)

Progressive muscle relaxation

EXPERIMENTAL

The researcher provided the intervention group participants face-to-face training on progressive relaxation exercises (PREs) at the first hospitalization. She had developed "A Guide to Progressive Relaxation Exercises" based on a literature review. The guide consisted of 22 steps. After the briefing, the researcher asked each intervention group participant to perform the PREs with voice instructions. The study continued with participants who performed the PRE steps correctly. While the participant was performing PREs, the researcher guided her verbally in line with the guide. After the nurse teaches the PRE technique once, the individual can apply it. Progressive relaxation exercises are performed for about 15-30 minutes.

Behavioral: Progressive muscle relaxation

Control

NO INTERVENTION

In this group, participant were assessed without any other intervention.

Interventions

This intervention consists of two parts. The first part gives short information about the content and how exercises should be done. It consists of information about deep relaxation. In the second part, there are relaxation exercises accompanied. Both the briefing and the intervention lasted 30 minutes for each patient.

Progressive muscle relaxation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergo CAG for the first time
  • has a chest score of 5 or less on the pain scale
  • has no history of mental disorder according to medical records
  • is able to communicate

You may not qualify if:

  • Admission to the intensive care unit after the CAG procedure
  • starting analgesic or perlinganit infusion
  • wanting to quit the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazıt University

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAnxiety Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tuğçe Türten Kaymaz, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Beyza Güney, MSc

    Duzce University Faculty of Medicine Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 29, 2024

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 24, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations