AnxietyNCT06676202
Progressive Relaxation Exercises on Anxiety Levels
A study testing Progressive Relaxation Exercises in people with Anxiety and Exercises Therapy, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Exercises Therapy, Total Knee Replacement Surgery
- What is being tested?
- Progressive Relaxation Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzincan Binali Yildirim Universty
Erzincan, Merkez, 24030
Meryem Fırat, +0904462261818, meryemfirat@hotmail.com
About this study
Official title: The Effect of Progressive Relaxation Exercises on Anxiety Levels in Patients Undergoing Total Knee Replacement Surgery: a Randomized Controlled Trial
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.
- Conditions
- Anxiety, Exercises Therapy, Total Knee Replacement Surgery
- Being tested
- Progressive Relaxation Exercises
- Keywords
- Anxiety, Exercises, Total Knee Replacement Surgery
- Medical subject headings
- Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | - 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 Receives: Behavioral: Progressive Relaxation Exercises |
| Control Group | No intervention | * 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the 12th, 24th and 48th hours after surgery
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.
Measured: at the 12th, 24th and 48th hours after surgery
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.
Measured: at the 12th, 24th and 48th hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem FIRAT, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676202
- Sponsor's protocol ID
- Ramazan_YENİ_YL_TEZ
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Anxiety Levels in Patients Undergoing Total Knee Replacement Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06676202
- Acronym / sponsor ID
- Ramazan_YENİ_YL_TEZ
- Conditions
- Anxiety, Exercises Therapy, Total Knee Replacement Surgery
- Keywords
- Anxiety, Exercises, Total Knee Replacement Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Progressive Relaxation Exercises- 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 |
| Control Group | No intervention | –* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Being under 18 years old
- Having speech and comprehension problems
- Not having total knee replacement surgery
- Early discharge after surgery
- Having complications after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Relaxation ExercisesIt 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. | Behavioural | Experimental group |
Primary outcome
Progressive relaxation exercises do not affect the anxiety level in patients who underwent total knee arthroplasty.
Time frame: at the 12th, 24th and 48th hours after surgery
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.
The anxiety level decreases after progressive relaxation exercises in patients who have undergone total knee arthroplasty.
Time frame: at the 12th, 24th and 48th hours after surgery
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.
The anxiety level increases after progressive relaxation exercises in patients who have undergone total knee arthroplasty.
Time frame: at the 12th, 24th and 48th hours after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises in people with Anxiety and Exercises Therapy, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryem Fırat (+0904462261818, meryemfirat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive relaxation exercises do not affect the anxiety level in patients who underwent total knee arthroplasty. (time frame: at the 12th, 24th and 48th hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.