NCT06871332

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.

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 Aug 2023

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

August 2, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

AnxietyFemoral SheathPainProgressive Relaxation ExerciseSatisfaction

Outcome Measures

Primary Outcomes (3)

  • Pain level

    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

    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

    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

Study Arms (2)

Progressive relaxation exercises group

EXPERIMENTAL

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

Other: Progressive relaxation exercise group

Control group

NO INTERVENTION

The patients in the control group received the standard practice of the clinic.

Interventions

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

Progressive relaxation exercises group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Talas, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

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.Dr.

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

August 2, 2023

Primary Completion

April 5, 2024

Study Completion

April 5, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations