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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06544512
Study groupRoleWhat they receive
the group that performed relaxation exercisesExperimentalThe 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 exercisesNo interventionThe 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.

  1. 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

  2. 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.

  1. First posted9 Aug 2024
  2. Study start1 Aug 2023
  3. Primary completion30 Mar 2024
  4. Study completion30 Mar 2024

Resources

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)
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

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; AzTrials last refreshed its copy on 8 Nov 2026.

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