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NCT Number: NCT06871332

Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction

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.

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Key information

Conditions

Effect of Progressive Relaxation Exercise Anxiety Disorders Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Talas, Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive relaxation exercise group

Other

Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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