Arthoplasty, Pain, AnxietyPMRENCT07098390
Effect of Progressive Muscle Relaxation on Fear of Falling, Pain, and Anxiety in Arthroplasty Patients
A study testing Progressive Muscle Relaxation Exercise in people with Arthoplasty, Pain, Anxiety, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted using a parallel-group randomized controlled experimental design to determine the effect of progressive muscle relaxation exercises on postoperative fear of falling, pain, and anxiety levels in patients undergoing total hip and knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthoplasty, Pain, Anxiety
- What is being tested?
- Progressive Muscle Relaxation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2025to 25 Mar 2026
- 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
- • Patients aged 18 years or older,
- Undergoing primary and elective hip or knee arthroplasty,
- Admitted to the clinic one day before surgery,
- Having no other acute illness that could cause pain or anxiety,
- Voluntarily agreeing to participate in the study,
- Able to communicate
Who cannot join
- • Diagnosed with any neurological or psychiatric disorder affecting cognitive status,
- Diagnosed with an anxiety disorder,
- Developing complications during the perioperative period,
- Undergoing active cancer treatment,
- Receiving chronic pain treatment
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, 1 recruiting
- Recruiting
Gazi University Hospital
Ankara
Zühal Erdoğan, RN, PhD, Assistant Professor, +90 312 202 34 44, zuhalerdogan@gazi.edu.tr
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercise Undergoing Total Hip and Knee Arthroplasty Patients on Fear of Falling, Pain and Anxiety Level
The study will be conducted using a parallel-group randomized controlled experimental design to determine the effect of progressive muscle relaxation exercises on postoperative fear of falling, pain, and anxiety levels in patients undergoing total hip and knee arthroplasty. The study group will consist of patients who have undergone total hip or knee arthroplasty in the Orthopedics and Traumatology Clinic of a university hospital.
Research data will be collected using the "Descriptive Information Form," the The Fear of Falling Scale, the Numeric Rating Scale (NRS), and the State-Trait Anxiety Inventory. Patients will be randomly assigned to intervention and control groups, and progressive muscle relaxation exercises will be applied to the patients in the intervention group.
Read the detailed description
When patients are admitted to the Orthopedics and Traumatology Clinic for arthroplasty and agree to participate in the study, they will be informed about the research process and written informed consent will be obtained. The Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory (STAI) will be administered through face-to-face interviews by the researcher. After the pre-tests are completed, patients will be randomly assigned to the intervention and control groups.
In the preoperative period, upon admission to the clinic, patients in the intervention group will receive progressive muscle relaxation exercises (PMRE). To enhance concentration and minimize the impact of ambient noise, patients will listen to the exercises using headphones.
On the first postoperative day, the patient will be revisited by the researcher. After the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will be administered, and the patient's pain and fear of falling will be evaluated. PMRE will then be performed, followed by the patient's first mobilization. One hour after mobilization, fear of falling, state-trait anxiety, and pain will be reassessed. The PMRE sessions, lasting approximately 30 minutes, will be guided with slow and rhythmic instructions, delivered in a soft tone of voice and accompanied by music.
For patients in the control group, the administration of the questionnaires will be conducted in the same manner as in the intervention group. Upon admission to the clinic, the Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory will be completed through face-to-face interviews. On the first postoperative day, the patient will be revisited by the researcher, and after the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will be administered again, and the patient's pain and fear of falling will be evaluated. The patient's first mobilization will then be carried out. One hour after mobilization, fear of falling, state-trait anxiety, and pain will be reassessed.
Pain assessment will begin from the second postoperative hour. Pain intensity will be evaluated every 2 hours for the first 8 hours and then every 4 hours thereafter. After the final assessments of the control group are completed, PMRE will be administered by the researcher.
- Conditions
- Arthoplasty, Pain, Anxiety
- Being tested
- Progressive Muscle Relaxation Exercise
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation ExerciseBehavioural
When patients are admitted to the Orthopedics and Traumatology Clinic for arthroplasty and agree to participate in the study, they will be informed about the research process and written informed consent will be obtained. The Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory (STAI) will be administered through face-to-face interviews by the researcher. After the pre-tests are completed, patients will be randomly assigned to the intervention and control groups.
In the preoperative period, upon admission to the clinic, patients in the intervention group will receive progressive muscle relaxation exercises (PMRE). To enhance concentration and minimize the impact of ambient noise, patients will listen to the exercises using headphones.
On the first postoperative day, the patient will be revisited by the researcher. After the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Exercise | Experimental | Not described Receives: Behavioral: Progressive Muscle Relaxation Exercise |
| Control | No intervention | Participants in this group will receive routine perioperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fear of Falling Scale
The Fear of Falling Scale consists of a single-item question asking participants to indicate their fear of falling on a four-point Likert scale: 1 = not afraid, 2 = slightly afraid, 3 = moderately afraid, and 4 = very afraid. This scale has been widely used in various studies, particularly among patients with hip fractures (Damar et al., 2018).
Measured: Baseline Twice a day on the first postoperative day
Numeric Rating Scale (NRS):
The Numeric Rating Scale is a unidimensional tool designed to assess the intensity of pain, allowing patients to express their pain using numbers. It is an 11-point scale ranging from 0 (no pain) to 10 (unbearable pain). Scores of 1-3 indicate mild pain, 4-6 indicate moderate pain, and 7-10 indicate severe pain. It is a valid and reliable tool for assessing postoperative pain in conscious patients
Measured: Baseline Pain assessment will begin at the 2nd hour after surgery. During the first 8 hours, pain intensity will be evaluated every 2 hours, and then every 4 hours thereafter.
State-Trait Anxiety Inventory (STAI):
The State-Trait Anxiety Inventory (STAI), developed by Spielberger et al. to measure individuals' levels of state and trait anxiety, was adapted into Turkish and validated by Öner and Le Compte (1977). The scale evaluates how individuals feel about themselves and consists of two subscales, both using a four-point Likert format.
The first part, the State Anxiety Scale, includes 20 items and assesses how the individual feels at a specific moment and under specific conditions (Öner, 1985).
The second part, the Trait Anxiety Scale, also includes 20 items and measures the individual's general tendency to experience anxiety. It was developed to reflect the anxiety experienced over the past seven days. Some items are reverse-scored when calculating the total score. In the State Anxiety Scale, 10 items (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) are reversed; in the Trait Anxiety Scale, 7 items (21, 26, 27, 30, 33, 36, 39) are reversed.
After reversing the scores of negatively worded items, the tota
Measured: Baseline Twice a day on the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start28 Jul 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthoplasty, Pain, AnxietyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zühal Erdoğan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098390
- Sponsor's protocol ID
- 2025 - 1072
- Acronym
- PMRE
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercise Undergoing Total Hip and Knee Arthroplasty Patients on Fear of Falling, Pain and Anxiety Level
- ClinicalTrials.gov ID
- NCT07098390
- Acronym / sponsor ID
- PMRE / 2025 - 1072
- Conditions
- Arthoplasty, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 1 Aug 2025 (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 study will be conducted using a parallel-group randomized controlled experimental design to determine the effect of progressive muscle relaxation exercises on postoperative fear of falling, pain, and anxiety levels in patients undergoing total hip and knee arthroplasty. The study group will consist of patients who have undergone total hip or knee arthroplasty in the Orthopedics and Traumatology Clinic of a university hospital.
Research data will be collected using the "Descriptive Information Form," the The Fear of Falling Scale, the Numeric Rating Scale (NRS), and the State-Trait Anxiety Inventory. Patients will be randomly assigned to intervention and control groups, and progressive muscle relaxation exercises will be applied to the patients in the intervention group.
Detailed description
When patients are admitted to the Orthopedics and Traumatology Clinic for arthroplasty and agree to participate in the study, they will be informed about the research process and written informed consent will be obtained. The Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory (STAI) will be administered through face-to-face interviews by the researcher. After the pre-tests are completed, patients will be randomly assigned to the intervention and control groups.
In the preoperative period, upon admission to the clinic, patients in the intervention group will receive progressive muscle relaxation exercises (PMRE). To enhance concentration and minimize the impact of ambient noise, patients will listen to the exercises using headphones.
On the first postoperative day, the patient will be revisited by the researcher. After the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will be administered, and the patient's pain and fear of falling will be evaluated. PMRE will then be performed, followed by the patient's first mobilization. One hour after mobilization, fear of falling, state-trait anxiety, and pain will be reassessed. The PMRE sessions, lasting approximately 30 minutes, will be guided with slow and rhythmic instructions, delivered in a soft tone of voice and accompanied by music.
For patients in the control group, the administration of the questionnaires will be conducted in the same manner as in the intervention group. Upon admission to the clinic, the Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory will be completed through face-to-face interviews. On the first postoperative day, the patient will be revisited by the researcher, and after the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will be administered again, and the patient's pain and fear of falling will be evaluated. The patient's first mobilization will then be carried out. One hour after mobilization, fear of falling, state-trait anxiety, and pain will be reassessed.
Pain assessment will begin from the second postoperative hour. Pain intensity will be evaluated every 2 hours for the first 8 hours and then every 4 hours thereafter. After the final assessments of the control group are completed, PMRE will be administered by the researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Exercise | Experimental | Behavioral: Progressive Muscle Relaxation Exercise |
| Control | No intervention | –Participants in this group will receive routine perioperative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients aged 18 years or older,
Key exclusion criteria (5 listed)
- • Diagnosed with any neurological or psychiatric disorder affecting cognitive status,
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 Muscle Relaxation ExerciseWhen patients are admitted to the Orthopedics and Traumatology Clinic for arthroplasty and agree to participate in the study, they will be informed about the research process and written informed consent will be obtained. The Descriptive Information Form, Numeric Rating Scale (NRS), The Fear of Falling Scale, and the State-Trait Anxiety Inventory (STAI) will be administered through face-to-face interviews by the researcher. After the pre-tests are completed, patients will be randomly assigned to the intervention and control groups. In the preoperative period, upon admission to the clinic, patients in the intervention group will receive progressive muscle relaxation exercises (PMRE). To enhance concentration and minimize the impact of ambient noise, patients will listen to the exercises using headphones. On the first postoperative day, the patient will be revisited by the researcher. After the physician explains that the patient will be mobilized, the State-Trait Anxiety Inventory will | Behavioural | Progressive Muscle Relaxation Exercise |
Primary outcome
The Fear of Falling Scale
Time frame: Baseline Twice a day on the first postoperative day
The Fear of Falling Scale consists of a single-item question asking participants to indicate their fear of falling on a four-point Likert scale: 1 = not afraid, 2 = slightly afraid, 3 = moderately afraid, and 4 = very afraid. This scale has been widely used in various studies, particularly among patients with hip fractures (Damar et al., 2018).
Numeric Rating Scale (NRS):
Time frame: Baseline Pain assessment will begin at the 2nd hour after surgery. During the first 8 hours, pain intensity will be evaluated every 2 hours, and then every 4 hours thereafter.
The Numeric Rating Scale is a unidimensional tool designed to assess the intensity of pain, allowing patients to express their pain using numbers. It is an 11-point scale ranging from 0 (no pain) to 10 (unbearable pain). Scores of 1-3 indicate mild pain, 4-6 indicate moderate pain, and 7-10 indicate severe pain. It is a valid and reliable tool for assessing postoperative pain in conscious patients
State-Trait Anxiety Inventory (STAI):
Time frame: Baseline Twice a day on the first postoperative day
The State-Trait Anxiety Inventory (STAI), developed by Spielberger et al. to measure individuals' levels of state and trait anxiety, was adapted into Turkish and validated by Öner and Le Compte (1977). The scale evaluates how individuals feel about themselves and consists of two subscales, both using a four-point Likert format. The first part, the State Anxiety Scale, includes 20 items and assesses how the individual feels at a specific moment and under specific conditions (Öner, 1985). The second part, the Trait Anxiety Scale, also includes 20 items and measures the individual's general tendency to experience anxiety. It was developed to reflect the anxiety experienced over the past seven days. Some items are reverse-scored when calculating the total score. In the State Anxiety Scale, 10 items (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) are reversed; in the Trait Anxiety Scale, 7 items (21, 26, 27, 30, 33, 36, 39) are reversed. After reversing the scores of negatively worded items, the tota
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 26 Aug 2025.
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 Muscle Relaxation Exercise in people with Arthoplasty, Pain, Anxiety, run by Gazi University 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 5 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: looking for participants now, as of the sponsor's last update on 26 Aug 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fear of Falling Scale (time frame: Baseline Twice a day on the first postoperative day). 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 26 Aug 2025.