Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction

Not Applicable

Completed

• Conditions: Effect of Progressive Relaxation Exercise

• Registration Number: NCT06871332
• Lead Sponsor: TC Erciyes University

Brief Summary

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.

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 Timeline

• Study Start: 2023-08-02
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain level	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.
Anxiety level	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.
Patient satisfaction	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.

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Talas, Kayseri, Turkey