Obesity, MorbidPREbariNCT05591898
The Effect of Progressive Relaxation Exercises on Bariatric Surgery Period
A study testing Progressive relaxation exercises in people with Obesity, Morbid and Bariatric Surgery Candidate, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to test the effect of the progressive relaxation exercises in perioperative bariatric surgery patient care. The investigators know that the preoperative anxiety is an important factor that affects acute postoperative pain experience. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate, Anxiety
- 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
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having bariatric surgery plan (such as sleeve gastrectomy, gastric bypass),
- 18 years and over,
- Do not have any medically diagnosed health problems (neurological, psychiatric, orthopedic) that will prevent learning and practicing progressive muscle relaxation exercises,
- Agreeing to apply progressive relaxation exercises, willing and willing to participate in the study,
- Patients who do not know and practice progressive relaxation exercises before will be included in the study.
Who cannot join
- Patients younger than 18 and older than 65,
- Patients who do not want to apply progressive relaxation exercises,
- who do not apply them as desired during the study period,
- who have health problems (neurological, psychiatric, orthopedic) that may affect their ability to do the exercises will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam & Sakura Şehir Hospital
Istanbul
About this study
Official title: The Effect of Progressive Relaxation Exercises on Preoperative Anxiety and Postoperative Pain in Bariatric Surgery Patients
The goal of this clinical trial is to test the effect of the progressive relaxation exercises in perioperative bariatric surgery patient care. The investigators know that the preoperative anxiety is an important factor that affects acute postoperative pain experience. Additionally, the investigators know that there is a relationship between preoperative anxiety and moderate to severe pain in the first 12 hours postoperatively, and this is also true for patients undergoing bariatric surgery. The main questions it aims to answer are:
- Does preoperative anxiety level of patient who will undergo bariatric surgery and who are applied progressive relaxation exercises is lower than those who did not apply exercise?
- Does postoperative pain level of patient who underwent bariatric surgery and applied progressive relaxation exercises was lower than patients who did not apply exercise?
Read more
Participants will be randomly split into two groups and one of the groups of participants will learn how to do progressive relaxation exercises preoperatively and the other group will learn nothing. Then at the time of the surgery, all participants will fill a survey preoperatively to analyze participants' anxiety level in each group and the investigators will collect data about participants' pain level postoperatively.
Researchers will compare these data whether there is an effect of the progressive relaxation exercises on preoperative anxiety and postoperative pain or not.
Read the detailed description
Preoperative anxiety is a defined factor that affects the acute postoperative pain experience. There is an evidence-based relationship between preoperative anxiety and moderate to severe pain in the first 12 hours postoperatively. Similarly, patients with high anxiety before bariatric surgery experienced more pain in the first postoperative hour. Interventions to reduce anxiety may decrease the surgical pain response and improve postoperative recovery by reducing the sympathetic nervous system response. There are various pharmacological and non-pharmacological methods (such as education, music, acupuncture, massage) used for preoperative anxiety. One of the non-pharmacological methods is progressive relaxation exercises. Progressive muscle relaxation is a relaxation technique developed by Edmund Jacobson in the 1920s. It is one of the simple and easy to learn relaxation techniques. These exercises involve contracting muscles to create tension and gradually releasing that tension. It is routinely repeated until complete relief is achieved. In the literature, there are studies on the effect of progressive relaxation exercises on anxiety and pain. In these studies, it was determined that progressive relaxation exercises reduce anxiety, pain, muscle tension, sleep disorders and fatigue levels. No study has been found on the effect of progressive relaxation exercises on preoperative anxiety and postoperative pain in bariatric surgery patients.
So, the investigators planned a study to determine the effect of progressive relaxation exercises on preoperative anxiety and postoperative pain in patients undergoing bariatric surgery.
Patients willing to have a bariatric surgery in our hospital will be split into two groups randomly and one of the groups of participants will be learnt how to do progressive relaxation exercises one month preoperatively and the other group will learn nothing. Then at the time of the surgery, all patients will fill a survey preoperatively to collect the participants' anxiety level in each group and pain scores will be collected postoperatively. All patients will give informed consent to join to the study.
H1: Preoperative anxiety level of patients who will undergo bariatric surgery and who are applied progressive relaxation exercises is lower than those who do not exercise.
H2: Postoperative pain level of patients who underwent bariatric surgery and applied progressive relaxation exercises was lower than patients who did not apply exercise.
Study arms are explained below.
- Being tested
- Progressive relaxation exercises
- Keywords
- bariatric surgery, Progressive relaxation exercises, anxiety, postoperative pain
- Medical subject headings
- Obesity, Morbid, 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 exercisesBehavioural
Training booklet and CD as a guide on the implementation of Progressive Relaxation Exercises prepared by the Turkish Psychological Association; muscle relaxation exercises, rhythmic breathing and music recital. In the first 10 minutes of this three-part CD, the definition and purpose of deep relaxation and the practices to be considered during exercise are explained. In the second part of 30 minutes; relaxation exercises are explained with the sound of the stream and verbal instructions. The third part, consisting of 30 minutes; it contains only relaxation music without instructions.
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation exercises group | Experimental | Participants will be randomly selected by a computer based system (Block randomization was used to keep the sample size of the groups similar. Random Allocation Software (Ver. 1.0.0) will be used to allocate the patients to groups). Selected participants will be invited to a meeting which will be held face-to-face and in a quiet environment. Progressive Relaxation Exercises will be explained to this group in a step-by-step manner whose surgery date is determined to undergo bariatric surgery by the relevant researcher. After this stage, participants will be followed to do the exercises regularly for a month by a researcher. Patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively at the hospital. After the surgery, the patients will be evaluated by the researchers in terms of pain scores and analgesic usage frequency in the recovery room and 1st, 4th, 8th, 12th, 24th, 36th and 48th hours data will be collected in the postoperative service. Receives: Behavioral: Progressive relaxation exercises |
| Control group | No intervention | This group will be the randomized selected patients who will not get any intervention. Patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively at the hospital. After the surgery, the patients will be evaluated by the researchers in terms of pain scores and analgesic usage frequency in the recovery room and 1st, 4th, 8th, 12th, 24th, 36th and 48th hours data will be collected in the postoperative service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety level
The Progressive relaxation exercises supposed to lower the preoperative anxiety level in bariatric surgery patients. The patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively. The Amsterdam Preoperative Anxiety and Information Scale is a self-report questionnaire composed of six questions that were developed and validated to evaluate a patient's preoperative anxiety. The range of the scale is between 6 to 30 and higher means more anxiety.
Measured: Preoperatively
Secondary outcomes (1)
Postoperative pain level
Progressive relaxation exercises supposed to lower the postoperative pain scores in the bariatric surgery patients. The pain score will be identified by using the visual analog scale (VAS) score. VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The range of the scale is between 0 to 10 and higher means more pain.
Measured: Postoperative pain scores collection is planned at the postoperative period in the first 48 hour after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Jan 2023
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Atlas University, Istanbul Medeniyet University
- Responsible party
- Principal investigator, Ismail Calikoglu, Başakşehir Çam & Sakura City Hospital
- Investigators
- İsmail Çalıkoğlu, M.D., Principal investigator, Başakşehir Çam & Sakura Şehir Hospitalİsmail Çalıkoğlu, Study director, Başakşehir Çam & Sakura Şehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591898
- Sponsor's protocol ID
- KAEK/2022.01.7
- Acronym
- PREbari
- Status last verified
- Jun 2023
- First submitted
- 18 Oct 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study will be reported as an article in a high quality journal.
Publications
Daniel S, Sindhu JV. Effectiveness of Progressive Muscle Relaxation Technique on Post Operative Pain and Anxiety Among patients Who Have Undergone Abdominal Surgery. International Journal of Nursing Critical Care. 2020; 6(1), 35-41.
David LA, Sijercic I, Cassin SE. Preoperative and post-operative psychosocial interventions for bariatric surgery patients: A systematic review. Obes Rev. 2020 Apr;21(4):e12926. doi: 10.1111/obr.12926. Epub 2020 Jan 22.
PubMed 31970925Felix MMDS, Ferreira MBG, Oliveira LF, Barichello E, Pires PDS, Barbosa MH. Guided imagery relaxation therapy on preoperative anxiety: a randomized clinical trial. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3101. doi: 10.1590/1518-8345.2850.3101.
PubMed 30517586Gravani S, Matiatou M, Nikolaidis PT, Menenakos E, Zografos CG, Zografos G, Albanopoulos K. Anxiety and Depression Affect Early Postoperative Pain Dimensions after Bariatric Surgery. J Clin Med. 2020 Dec 25;10(1):53. doi: 10.3390/jcm10010053.
PubMed 33375765Alvarez-Garcia C, Yaban ZS. The effects of preoperative guided imagery interventions on preoperative anxiety and postoperative pain: A meta-analysis. Complement Ther Clin Pract. 2020 Feb;38:101077. doi: 10.1016/j.ctcp.2019.101077. Epub 2019 Dec 4.
PubMed 32056813
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Preoperative Anxiety and Postoperative Pain in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT05591898
- Acronym / sponsor ID
- PREbari / KAEK/2022.01.7
- Keywords
- bariatric surgery, Progressive relaxation exercises, anxiety, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Atlas University, Istanbul Medeniyet University
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 24 Oct 2022 (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 goal of this clinical trial is to test the effect of the progressive relaxation exercises in perioperative bariatric surgery patient care. The investigators know that the preoperative anxiety is an important factor that affects acute postoperative pain experience. Additionally, the investigators know that there is a relationship between preoperative anxiety and moderate to severe pain in the first 12 hours postoperatively, and this is also true for patients undergoing bariatric surgery. The main questions it aims to answer are:
- Does preoperative anxiety level of patient who will undergo bariatric surgery and who are applied progressive relaxation exercises is lower than those who did not apply exercise?
- Does postoperative pain level of patient who underwent bariatric surgery and applied progressive relaxation exercises was lower than patients who did not apply exercise?
Participants will be randomly split into two groups and one of the groups of participants will learn how to do progressive relaxation exercises preoperatively and the other group will learn nothing. Then at the time of the surgery, all participants will fill a survey preoperatively to analyze participants' anxiety level in each group and the investigators will collect data about participants' pain level postoperatively.
Researchers will compare these data whether there is an effect of the progressive relaxation exercises on preoperative anxiety and postoperative pain or not.
Detailed description
Preoperative anxiety is a defined factor that affects the acute postoperative pain experience. There is an evidence-based relationship between preoperative anxiety and moderate to severe pain in the first 12 hours postoperatively. Similarly, patients with high anxiety before bariatric surgery experienced more pain in the first postoperative hour. Interventions to reduce anxiety may decrease the surgical pain response and improve postoperative recovery by reducing the sympathetic nervous system response. There are various pharmacological and non-pharmacological methods (such as education, music, acupuncture, massage) used for preoperative anxiety. One of the non-pharmacological methods is progressive relaxation exercises. Progressive muscle relaxation is a relaxation technique developed by Edmund Jacobson in the 1920s. It is one of the simple and easy to learn relaxation techniques. These exercises involve contracting muscles to create tension and gradually releasing that tension. It is routinely repeated until complete relief is achieved. In the literature, there are studies on the effect of progressive relaxation exercises on anxiety and pain. In these studies, it was determined that progressive relaxation exercises reduce anxiety, pain, muscle tension, sleep disorders and fatigue levels. No study has been found on the effect of progressive relaxation exercises on preoperative anxiety and postoperative pain in bariatric surgery patients.
So, the investigators planned a study to determine the effect of progressive relaxation exercises on preoperative anxiety and postoperative pain in patients undergoing bariatric surgery.
Patients willing to have a bariatric surgery in our hospital will be split into two groups randomly and one of the groups of participants will be learnt how to do progressive relaxation exercises one month preoperatively and the other group will learn nothing. Then at the time of the surgery, all patients will fill a survey preoperatively to collect the participants' anxiety level in each group and pain scores will be collected postoperatively. All patients will give informed consent to join to the study.
H1: Preoperative anxiety level of patients who will undergo bariatric surgery and who are applied progressive relaxation exercises is lower than those who do not exercise.
H2: Postoperative pain level of patients who underwent bariatric surgery and applied progressive relaxation exercises was lower than patients who did not apply exercise.
Study arms are explained below.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation exercises group | Experimental | Behavioral: Progressive relaxation exercisesParticipants will be randomly selected by a computer based system (Block randomization was used to keep the sample size of the groups similar. Random Allocation Software (Ver. 1.0.0) will be used to allocate the patients to groups). Selected participants will be invited to a meeting which will be held face-to-face and in a quiet environment. Progressive Relaxation Exercises will be explained to this group in a step-by-step manner whose surgery date is determined to undergo bariatric surgery by the relevant researcher. After this stage, participants will be followed to do the exercises regularly for a month by a researcher. Patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively at the hospital. After the surgery, the patients will be evaluated by the researchers in terms of pain scores and analgesic usage frequency in the recovery room and 1st, 4th, 8th, 12th, 24th, 36th and 48th hours data will be collected in the postoperative service. |
| Control group | No intervention | –This group will be the randomized selected patients who will not get any intervention. Patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively at the hospital. After the surgery, the patients will be evaluated by the researchers in terms of pain scores and analgesic usage frequency in the recovery room and 1st, 4th, 8th, 12th, 24th, 36th and 48th hours data will be collected in the postoperative service. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having bariatric surgery plan (such as sleeve gastrectomy, gastric bypass),
- 18 years and over,
- Do not have any medically diagnosed health problems (neurological, psychiatric, orthopedic) that will prevent learning and practicing progressive muscle relaxation exercises,
- Agreeing to apply progressive relaxation exercises, willing and willing to participate in the study,
- Patients who do not know and practice progressive relaxation exercises before will be included in the study.
Key exclusion criteria (4 listed)
- Patients younger than 18 and older than 65,
- Patients who do not want to apply progressive relaxation exercises,
- who do not apply them as desired during the study period,
- who have health problems (neurological, psychiatric, orthopedic) that may affect their ability to do the exercises will be excluded from 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 exercisesTraining booklet and CD as a guide on the implementation of Progressive Relaxation Exercises prepared by the Turkish Psychological Association; muscle relaxation exercises, rhythmic breathing and music recital. In the first 10 minutes of this three-part CD, the definition and purpose of deep relaxation and the practices to be considered during exercise are explained. In the second part of 30 minutes; relaxation exercises are explained with the sound of the stream and verbal instructions. The third part, consisting of 30 minutes; it contains only relaxation music without instructions. | Behavioural | Progressive relaxation exercises group |
Primary outcome
Preoperative anxiety level
Time frame: Preoperatively
The Progressive relaxation exercises supposed to lower the preoperative anxiety level in bariatric surgery patients. The patients will fill the Amsterdam Preoperative Anxiety and Information Score Scale preoperatively. The Amsterdam Preoperative Anxiety and Information Scale is a self-report questionnaire composed of six questions that were developed and validated to evaluate a patient's preoperative anxiety. The range of the scale is between 6 to 30 and higher means more anxiety.
1 secondary outcome
Postoperative pain level
Time frame: Postoperative pain scores collection is planned at the postoperative period in the first 48 hour after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- BackgroundDaniel S, Sindhu JV. Effectiveness of Progressive Muscle Relaxation Technique on Post Operative Pain and Anxiety Among patients Who Have Undergone Abdominal Surgery. International Journal of Nursing Critical Care. 2020; 6(1), 35-41.
- Background: PubMed 31970925David LA, Sijercic I, Cassin SE. Preoperative and post-operative psychosocial interventions for bariatric surgery patients: A systematic review. Obes Rev. 2020 Apr;21(4):e12926. doi: 10.1111/obr.12926. Epub 2020 Jan 22.
- Background: PubMed 30517586Felix MMDS, Ferreira MBG, Oliveira LF, Barichello E, Pires PDS, Barbosa MH. Guided imagery relaxation therapy on preoperative anxiety: a randomized clinical trial. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3101. doi: 10.1590/1518-8345.2850.3101.
- Background: PubMed 33375765Gravani S, Matiatou M, Nikolaidis PT, Menenakos E, Zografos CG, Zografos G, Albanopoulos K. Anxiety and Depression Affect Early Postoperative Pain Dimensions after Bariatric Surgery. J Clin Med. 2020 Dec 25;10(1):53. doi: 10.3390/jcm10010053.
- Results publication: PubMed 32056813Alvarez-Garcia C, Yaban ZS. The effects of preoperative guided imagery interventions on preoperative anxiety and postoperative pain: A meta-analysis. Complement Ther Clin Pract. 2020 Feb;38:101077. doi: 10.1016/j.ctcp.2019.101077. Epub 2019 Dec 4.
- Individual participant dataSharing planned: No. The results of the study will be reported as an article in a high quality journal.
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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.
İsmail Çalıkoğlu, M.D. principal investigator
Başakşehir Çam & Sakura Şehir Hospital
İsmail Çalıkoğlu study director
Başakşehir Çam & Sakura Şehir Hospital
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 Obesity, Morbid and Bariatric Surgery Candidate, run by Başakşehir Çam & Sakura City Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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?
Results are not available in the source record.
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?
Preoperative anxiety level (time frame: Preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591898, which also lists 5 linked publications.
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 22 Jun 2023.