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Not yet recruitingNCT06676202Updated Nov 6, 2024

Progressive Relaxation Exercises on Anxiety Levels

An interventional study of Progressive Relaxation Exercises in Anxiety, Exercises Therapy and Total Knee Replacement Surgery, sponsored by Erzincan Binali Yildirim Universitesi. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Erzincan Binali Yildirim Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The research will be conducted to determine the effect of progressive relaxation exercises on the anxiety level of patients who have had total knee replacement surgery.

Read the detailed description

The sample will not be selected from the universe and all patients who meet the inclusion criteria will constitute the sample. The minimum sample size of the study was determined by performing power analysis with the G-power 3.1.9.4 program. In the calculation made according to the two-way independent samples t-test, the effect size was taken as 0.80, with a margin of error of 0.05 and a power of 90%, the total sample number was calculated as 60 (Cohen, 1998). Considering the losses within the scope of the study, 66 patients who meet the inclusion criteria will be randomly divided into the experimental group (33 patients) and the control group (33). Finally, in order to minimize the risk of contamination, the first 33 patients who meet the inclusion criteria after being admitted to the clinic will constitute the control group, and the following 33 patients will constitute the experimental group.

Data will be collected using the 'Patient Identification Form' and the 'Beck Anxiety Scale'.

Progressive relaxation exercises were first applied by Dr. It is a technique of voluntary muscle contraction and relaxation developed by Edmund Jacobson in the 1920s. The main purpose of progressive relaxation exercises is for patients to understand the difference between muscle relaxation and tension and to be able to relax on their own. It combines the contraction and relaxation of large muscle groups such as the face, arms, legs, neck and back with deep breathing exercises. Before applying progressive relaxation exercises, the environment should be quiet, dimly lit, in a comfortable chair or armchair, sitting or lying down, and clothing should be loose and comfortable, and it is recommended to apply it one hour after eating. In the application of progressive relaxation exercises, it is first asked to breathe regularly. After our breathing rhythm is regulated, the hands, arm muscles, shoulder and neck muscles, chest, abdominal and hip muscles, legs, feet and facial muscles are contracted with a 5-7 second breathing exercise and relaxed during exhalation. This is repeated with 4-5 breathing exercises for each muscle and the exercise is ended when the eyelids are opened.

02

Conditions studied

  • Anxiety
  • Exercises Therapy
  • Total Knee Replacement Surgery

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Keywords

  • Anxiety
  • Exercises
  • Total Knee Replacement Surgery
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 66 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Erzincan Binali Yildirim Universitesi is the lead sponsor of 23 studies on the registry; 10 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being 18 years old and above
  • Speaking and understanding Turkish
  • Having total knee replacement surgery
  • Staying in the ward for approximately 96 hours after surgery
  • Volunteering to participate in the study
  • Not having a psychiatric diagnosis

Exclusion criteria

Exclusion Criteria:

  • Being under 18 years old
  • Having speech and comprehension problems
  • Not having total knee replacement surgery
  • Early discharge after surgery
  • Having complications after surgery
  • Not volunteering to participate in the study
  • Having a psychiatric diagnosis
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Experimental group

    - The patient will be given progressive relaxation exercises at the 12th, 24th, and 48th hours after the surgery. Before the application, information will be obtained about whether the patient has any complications and patients who develop complications due to the surgery will be excluded from the research group. As a result of the screening of progressive relaxation exercise studies in the literature, no standard duration and frequency information was found regarding the effectiveness of progressive relaxation exercise (Haut et al, 2018). In the literature review, it is seen that the total number of sessions varies as well as different applications such as being applied at the 6th, 12th, 24th hours after surgery or on the 2nd day after surgery (Tanrıverdi, 2021). In addition, studies conducted to reduce anxiety, pain, and stress after surgery may vary according to the length of hospitalization (Sertbaş and Bahar, 2004). Based on this information, it was learned that the approximate h

    Behavioral: Progressive Relaxation Exercises

  • No intervention
    Control Group

    * After the 33 patients admitted to the clinic, the "Patient Introduction Form" and "Beck Anxiety Scale" will be filled out after information and consent. * After the total knee replacement surgery, 50 hours will be waited and then the "Patient Introduction Form" and "Beck Anxiety Scale" will be filled out again. * Progressive relaxation exercises will not be applied to the control group patients, but the pre-test and post-test data will be applied in the same time periods as the experimental group. * Pre-test application 1 day before the surgery (Since the patient may be too tense just before the surgery, 1 day before was preferred. Patients who are taken to surgery on the same day due to an emergency will be excluded from the research group.) * Post-test application 50 hours after the surgery and later (Relaxation exercises will be applied to the experimental group at 12-24 and 48 hours. The 48th hour, when the exercise ends, will not be preferred for the post-test, the patient

Interventions

  • BehavioralProgressive Relaxation Exercises

    It combines the contraction and relaxation of large muscle groups such as the face, arms, legs, neck and back with deep breathing exercises. Before applying progressive relaxation exercises, the environment should be quiet, dimly lit, a comfortable chair or armchair should be sat or lying down, and clothing should be loose and comfortable, and it is recommended to apply it one hour after eating. In the application of progressive relaxation exercises, it is first asked to breathe regularly. After our breathing rhythm is regulated, the hands, arm muscles, shoulder and neck muscles, chest, abdominal and hip muscles, legs, feet and facial muscles are contracted with a 5-7 second breathing exercise and relaxed during exhalation. This is repeated with 4-5 breathing exercises for each muscle and the exercise is ended when the eyelids are opened.

06

What researchers measure

Primary outcomes

  1. Progressive relaxation exercises do not affect the anxiety level in patients who underwent total knee arthroplasty.

    In order to assess the anxiety level of the patients, the Beck Anxiety Scale will be administered at the 12th, 24th and 48th hours after surgery.

    Time frame: at the 12th, 24th and 48th hours after surgery

  2. The anxiety level decreases after progressive relaxation exercises in patients who have undergone total knee arthroplasty.

    In order to assess the anxiety level of the patients, the Beck Anxiety Scale will be administered at the 12th, 24th and 48th hours after surgery.

    Time frame: at the 12th, 24th and 48th hours after surgery

  3. The anxiety level increases after progressive relaxation exercises in patients who have undergone total knee arthroplasty.

    In order to assess the anxiety level of the patients, the Beck Anxiety Scale will be administered at the 12th, 24th and 48th hours after surgery.

    Time frame: at the 12th, 24th and 48th hours after surgery

07

Study locations

1 site
  • Erzincan Binali Yildirim Universty
    Erzincan, Merkez 24030, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06676202
Lead sponsor
Erzincan Binali Yildirim Universitesi
Responsible party
Meryem FIRAT (Erzincan University, Erzincan University) — Principal investigator
First posted
Nov 6, 2024
Start date
Nov 30, 2024 (estimated)
Primary completion
May 30, 2025 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Nov 6, 2024

Study contacts

Meryem Fırat
Contact
meryemfirat@hotmail.com
+0904462261818

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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