Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction

March 6, 2025 updated by: Sevda Korkut, TC Erciyes University

The Effect of Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction Related to Femoral Sheath Removal: a Randomized Controlled Study

This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aimed to determine the effect of progressive relaxation exercise (PRE) applied to patients undergoing percutaneous coronary intervention (PCI) on pain, anxiety and patient satisfaction related to femoral sheath removal. This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed PRE for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kayseri
      • Talas, Kayseri, Turkey, 38039
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • able to speak and understand Turkish,
  • over 18 years of age,
  • intervened in the femoral region,
  • with only one catheter in the femoral region,
  • without vision and hearing problems,
  • undergoing angiography procedure for the first time,
  • with normal vital signs,
  • who have not been administered analgesics for any reason prior to sheath removal after the procedure,
  • patients who volunteered to participate in the study were included in the study.

Exclusion Criteria:

  • patients with chronic pain using transdermal patches,
  • patients with impaired time and place orientation,
  • patients with psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive relaxation exercises group
Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal.
Other: Progressive relaxation exercise group
Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal.
No Intervention: Control group
The patients in the control group received the standard practice of the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: One minute after femoral sheath removal
Patients' pain is evaluated with the Visual Analog Scale (VAS) .The VAS is a 10 cm long ruler drawn horizontally or vertically. Patients were told that 0 on the scale means no pain and 10 means unbearable pain at the highest level. The patient was asked to mark the point on this scale indicating the level of pain they felt.
One minute after femoral sheath removal
Anxiety level
Time Frame: One minute after femoral sheath removal
Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. patients were told that 0 on the scale means no anxiety and 10 means unbearable anxiety at the highest level. The patient was asked to mark the point on this scale indicating the level of anxiety they felt.
One minute after femoral sheath removal
Patient satisfaction
Time Frame: One minute after sheath removal
Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. It was explained to the patient that the number 0 indicated no satisfaction with the application and the number 10 indicated the highest level of satisfaction and the patient was asked to mark on the ruler.
One minute after sheath removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Actual)

April 5, 2024

Study Completion (Actual)

April 5, 2024

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022/543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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