AnxietyNCT06544512
Effect of PMR on Anxiety and Pain Level in Patients Undergoing Obesity Surgery
A study testing progressive relaxation exercise in people with Anxiety and Pain, Postoperative, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are: Do progressive relaxation exercises reduce participants' pain levels? Do progressive relaxation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety, Pain, Postoperative
- What is being tested?
- progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- He will experience obesity surgery surgery as planned for the first time
- Who volunteered to participate in the research 18 years and over
- The mental state is healthy
- Without vision, hearing and speech problems
- Patients who know Turkish will be included in the study.
Who cannot join
- The patient has had bariatric surgery before,
- Have previously applied progressive relaxation exercises,
- Having a communication problem,
- Progressive relaxation exercise prevents the practice of health problems (epilepsy, bipolar disorder, schizophrenia, fever, infection, etc.) to be
- It has been determined that the patient does not want to be involved in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University Dursun Odabaş Medical Center
Van, 65000
About this study
Official title: Investigation of the Effect of Progressive Relaxation Exercises on Anxiety and Pain Level in Patients Undergoing Obesity Surgery
The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:
- Do progressive relaxation exercises reduce participants' pain levels?
- Do progressive relaxation exercises reduce participants' anxiety levels? The researchers will compare the effect of progressive relaxation exercises on the level of anxiety and pain between experimental and control groups .
Participants:
- He will experience obesity surgery surgery as planned for the first time
- Who volunteered to participate in the research
- 18 years and over
- The mental state is healthy
Read the detailed description
Obesity, which has been increasing in frequency in recent years, is a public health problem that many factors such as age, gender, education level, marital status and lack of physical activity are responsible for. The treatment of obesity can be divided into several stages: diet, physical activity, medical treatment and surgical treatment. Obesity surgery is resorted to in cases where diet therapy or medical treatment accompanied by physical activity does not give results. The sick individual is concerned both as a result of the physical effects of the disease on himself or as a result of the environmental change brought about by hospitalization. Encountering procedures that cause physical pain, being away from family, losing one's job, encountering unknown tools and procedures are some of the factors that may cause the hospitalized individual to feel anxiety. Having surgery is also among these factors and occupies an important place. Surgery includes the meanings of pain for the patient, loss of independence, deterioration in body image, and each of these elements is perceived as a threat. Nonpharmacological treatment to reduce postoperative pain and anxiety; the patient can be relieved by using methods such as diverting attention, listening to music, relaxation, breathing techniques, meditation, hypnosis. Progressive relaxation exercises are one of these methods. Progressive relaxation exercises involve the voluntary stretching and Novation of all muscle groups in the human body. Progressive relaxation exercise is a type of exercise that relaxes a person physically and spiritually, reduces a person's blood pressure, pain sensitivity, fatigue, stress, anxiety, heart rate, and positively affects a person physically and spiritually.The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:
- Do progressive relaxation exercises reduce participants' pain levels?
- Do progressive relaxation exercises reduce participants' anxiety levels? This research is planned to be conducted at the General Surgery Clinic of Van Yüzüncü Yıl University Dursun Odabaş Medical Center between August 2023- March 2024. The research is planned to be conducted in the General Surgery Clinic of Van Yüzüncü Yil University. Dependent Variables: State-Trait Anxiety scale, VAS Pain Scale Independent Variables: Training in progressive relaxation exercises Control Variables: the patient's age, gender, marital status, educational level, the status of having had surgery before, the status of having another health problem.
Collection of Data and Initiatives:Firstly, approval from the Ethics Committee of Atatürk University Faculty of Medicine and written permissions from the hospitals where the research will be conducted were obtained for the research. The "Patient Introduction Form", the "Condition-Continuity Anxiety Scale", the "Visual Analog Scale (VAS) Pain Form" will be used in the collection of research data. The data collection tools will be applied as follows: Questionnaires will be filled out by the researcher to the patients using the face-to-face interview technique.The scales will be introduced and the Patient Introduction form, the Status-Trait Anxiety Scale and the Visual Analog Scale (VAS) Pain Form will be completed. Later relaxation exercises will be performed during a session lasting 30 minutes, and after the session, the State-Trait Anxiety Scale and the Visual Analog Scale (VAS) Pain Form will be re-applied to patients.
- Conditions
- Anxiety, Pain, Postoperative
- Being tested
- progressive relaxation exercise
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
looking at pain and anxiety by practicing progressive relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| the group that performed relaxation exercises | Experimental | The group that received progressive relaxation exercise and filled out the pain and state-trait anxiety scales Receives: Other: progressive relaxation exercise |
| the group that did not do relaxation exercises | No intervention | The group that did not receive progressive relaxation exercise and only filled out the pain and state-trait anxiety scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS( Visual Analog Scale)
It is a scale with two different names on the two ends on a 10 cm long vertical or horizontal line (0=no pain, 10=most severe pain). The patient is asked to mark the point on this line that corresponds to the intensity of pain he feels.
Measured: on the day of the surgery
State-Trait Anxiety Scale
The State-Trait Anxiety Inventory, which was adapted to Turkish culture by Öner and Le Compte (1983), and in which validity and reliability studies were conducted as well as norm studies, consists of a total of 40 items, including a State Anxiety Scale consisting of 20 items and a Trait Anxiety Scale consisting of 20 items. According to the "Item Remainder" correlation technique, which provides detailed information about the reliability and validity of the items forming the scale; the item reliability correlations of the Turkish form are between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale.
Measured: on the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- intervention and control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şuheda Zorer, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544512
- Sponsor's protocol ID
- AtaturkUNI00
- Status last verified
- Dec 2024
- First submitted
- 2 May 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Progressive Relaxation Exercises on Anxiety and Pain Level in Patients Undergoing Obesity Surgery
- ClinicalTrials.gov ID
- NCT06544512
- Acronym / sponsor ID
- AtaturkUNI00
- Conditions
- Anxiety, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 9 Aug 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 aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:
- Do progressive relaxation exercises reduce participants' pain levels?
- Do progressive relaxation exercises reduce participants' anxiety levels? The researchers will compare the effect of progressive relaxation exercises on the level of anxiety and pain between experimental and control groups .
Participants:
- He will experience obesity surgery surgery as planned for the first time
- Who volunteered to participate in the research
- 18 years and over
- The mental state is healthy
Detailed description
Obesity, which has been increasing in frequency in recent years, is a public health problem that many factors such as age, gender, education level, marital status and lack of physical activity are responsible for. The treatment of obesity can be divided into several stages: diet, physical activity, medical treatment and surgical treatment. Obesity surgery is resorted to in cases where diet therapy or medical treatment accompanied by physical activity does not give results. The sick individual is concerned both as a result of the physical effects of the disease on himself or as a result of the environmental change brought about by hospitalization. Encountering procedures that cause physical pain, being away from family, losing one's job, encountering unknown tools and procedures are some of the factors that may cause the hospitalized individual to feel anxiety. Having surgery is also among these factors and occupies an important place. Surgery includes the meanings of pain for the patient, loss of independence, deterioration in body image, and each of these elements is perceived as a threat. Nonpharmacological treatment to reduce postoperative pain and anxiety; the patient can be relieved by using methods such as diverting attention, listening to music, relaxation, breathing techniques, meditation, hypnosis. Progressive relaxation exercises are one of these methods. Progressive relaxation exercises involve the voluntary stretching and Novation of all muscle groups in the human body. Progressive relaxation exercise is a type of exercise that relaxes a person physically and spiritually, reduces a person's blood pressure, pain sensitivity, fatigue, stress, anxiety, heart rate, and positively affects a person physically and spiritually.The aim of this clinical trial is to find out whether progressive relaxation exercises work on the effect of anxiety and pain level in patients undergoing obesity surgery. The main questions that it aims to answer are:
- Do progressive relaxation exercises reduce participants' pain levels?
- Do progressive relaxation exercises reduce participants' anxiety levels? This research is planned to be conducted at the General Surgery Clinic of Van Yüzüncü Yıl University Dursun Odabaş Medical Center between August 2023- March 2024. The research is planned to be conducted in the General Surgery Clinic of Van Yüzüncü Yil University. Dependent Variables: State-Trait Anxiety scale, VAS Pain Scale Independent Variables: Training in progressive relaxation exercises Control Variables: the patient's age, gender, marital status, educational level, the status of having had surgery before, the status of having another health problem.
Collection of Data and Initiatives:Firstly, approval from the Ethics Committee of Atatürk University Faculty of Medicine and written permissions from the hospitals where the research will be conducted were obtained for the research. The "Patient Introduction Form", the "Condition-Continuity Anxiety Scale", the "Visual Analog Scale (VAS) Pain Form" will be used in the collection of research data. The data collection tools will be applied as follows: Questionnaires will be filled out by the researcher to the patients using the face-to-face interview technique.The scales will be introduced and the Patient Introduction form, the Status-Trait Anxiety Scale and the Visual Analog Scale (VAS) Pain Form will be completed. Later relaxation exercises will be performed during a session lasting 30 minutes, and after the session, the State-Trait Anxiety Scale and the Visual Analog Scale (VAS) Pain Form will be re-applied to patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention and control
| Arm | Type | Receives |
|---|---|---|
| the group that performed relaxation exercises | Experimental | Other: progressive relaxation exerciseThe group that received progressive relaxation exercise and filled out the pain and state-trait anxiety scales |
| the group that did not do relaxation exercises | No intervention | –The group that did not receive progressive relaxation exercise and only filled out the pain and state-trait anxiety scales |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- He will experience obesity surgery surgery as planned for the first time
- Who volunteered to participate in the research 18 years and over
- The mental state is healthy
- Without vision, hearing and speech problems
- Patients who know Turkish will be included in the study.
Key exclusion criteria (5 listed)
- The patient has had bariatric surgery before,
- Have previously applied progressive relaxation exercises,
- Having a communication problem,
- Progressive relaxation exercise prevents the practice of health problems (epilepsy, bipolar disorder, schizophrenia, fever, infection, etc.) to be
- It has been determined that the patient does not want to be involved in the study
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 exerciselooking at pain and anxiety by practicing progressive relaxation exercises | Other | the group that performed relaxation exercises |
Primary outcome
VAS( Visual Analog Scale)
Time frame: on the day of the surgery
It is a scale with two different names on the two ends on a 10 cm long vertical or horizontal line (0=no pain, 10=most severe pain). The patient is asked to mark the point on this line that corresponds to the intensity of pain he feels.
State-Trait Anxiety Scale
Time frame: on the day of the surgery
The State-Trait Anxiety Inventory, which was adapted to Turkish culture by Öner and Le Compte (1983), and in which validity and reliability studies were conducted as well as norm studies, consists of a total of 40 items, including a State Anxiety Scale consisting of 20 items and a Trait Anxiety Scale consisting of 20 items. According to the "Item Remainder" correlation technique, which provides detailed information about the reliability and validity of the items forming the scale; the item reliability correlations of the Turkish form are between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 exercise in people with Anxiety and Pain, Postoperative, run by Ataturk 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 5 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: finished, as of the sponsor's last update on 11 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS( Visual Analog Scale) (time frame: on the day of the surgery). The study lists 2 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 11 Dec 2024.