NCT06572670

Brief Summary

This study was planned to examine the effects of progressive relaxation exercise on anxiety, comfort, pain and physiological parameters in patients undergoing coronary angiography. The data of the study will be collected using the Descriptive Characteristics Questionnaire Form, State and Trait Anxiety Inventory, Perianesthesia Comfort Questionnaire, Visual Analog Scale (VAS), Vital Signs Follow-up Form, Complication Follow-up Form and Progressive Relaxation Exercise Application Guidelines.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 23, 2024

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anxiety level

    This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings. The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days.

    30 minutes after angiography

  • Comfort level

    The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences.

    30 minutes after angiography

  • Pain level

    Pain will be assessed with the Visual Analog Scale. This scale consists of a 10 cm line with values between 0 and 10. The beginning of the line (number 0) indicates "no pain", while the end of the line (number 10) indicates the most severe pain.

    30 minutes after angiography

Secondary Outcomes (3)

  • Blood pressure to be assessed with monitor

    30 minutes after angiography

  • Pulse to be assessed with monitor

    30 minutes after angiography

  • Respiratory rate

    30 minutes after angiography

Study Arms (2)

Progressive relaxation exercise before coronary angiography

EXPERIMENTAL

Patients in the intervention group will undergo progressive relaxation before undergoing angiography.

Other: Progressive relaxation exercise before coronary angiography

Control group

NO INTERVENTION

No application will be made to the control group before the procedure.

Interventions

Patients in the intervention group will undergo progressive relaxation before undergoing angiography.

Progressive relaxation exercise before coronary angiography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who can speak and understand Turkish,
  • Are over 18 years old,
  • Have space and time orientation,
  • Will undergo coronary angiography for the first time,
  • Do not have any psychiatric illness,
  • Do not have vision or hearing problems,
  • Volunteer to participate in the study will be included.

You may not qualify if:

  • Patients who experience any pain or have chronic pain before coronary angiography,
  • Patients who use antihistamines and psychiatric medications,
  • Patients who do not volunteer to participate in the study,
  • Patients who have undergone orthopedic surgery or have any medically diagnosed health problems (orthopedic, neurological, psychological) that prevent relaxation exercises,
  • Patients who have taken sedatives or painkillers up to 5 hours before coronary angiography will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start

September 15, 2024

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share