Clinical trial NCT06676202: Progressive Relaxation Exercises on Anxiety Levels
Official title: The Effect of Progressive Relaxation Exercises on Anxiety Levels in Patients Undergoing Total Knee Replacement Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Exercises Therapy
Total Knee Replacement Surgery
Keywords: Anxiety
Exercises
Total Knee Replacement Surgery
Lead sponsor: Erzincan Binali Yildirim Universitesi
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Progressive relaxation exercises do not affect the anxiety level in patients who underwent total knee arthroplasty.
timeFrame: at the 12th, 24th and 48th hours after surgery
measure: The anxiety level decreases after progressive relaxation exercises in patients who have undergone total knee arthroplasty.
timeFrame: at the 12th, 24th and 48th hours after surgery
measure: The anxiety level increases after progressive relaxation exercises in patients who have undergone total knee arthroplasty.
timeFrame: at the 12th, 24th and 48th hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Binali Yildirim Universty
state: Merkez
Study officials:
References: