Clinical trial NCT05992662: Minfulness-Based Training Program in Bariatric Surgery Patients
Official title: Mindfulness-Based Training Program in Bariatric Surgery Patients: An Action Research
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: bariatric surgery
mindfulness
mindful eating
training program
surgery nursing
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bariatric surgery maintains its place in the literature as the most effective treatment method for obesity. In order for the surgery to be effective, it is important for individuals to adapt to the surgical process. This process has become more manageable with lifestyle changes and health education. Mindfulness practices are (useful forms of intervention) for practicing and restructuring the brain for healthier eating habits. The results of mindfulness studies show that mindful eating practices can be effective in the prevention and treatment of obesity. Studies on mindfulness in obesity are increasing rapidly in the literature; however, few studies have tested this approach in bariatric surgery patients. This research was planned in an action research design to examine the effect of mindfulness-based education program on individuals' mindful eating in bariatric surgery patients. As an action in the research, an mindfullness-based training program will be developed for the bariatric patient group. Then, in the preoperative period, a four-week, weekly session of mindfulness-based exercise and eating training will be given to the action group as an intervention. Mindful Eating Questionnaire will be applied to all participants (action and control group) before the training, and data will be collected from the action group with the vignette technique. A short cut story will be prepared, and the participants will be asked to complete the short story in written form. At the end of the training sessions, a focus group discussion will be held with the participants. An in-depth interview will be conducted with each participant in line with the semi-structured interview form in the third and sixth months after the surgery. The Mindful Eating Questionnaire will be readministered to both the action group and the control group. During and after the training, participants will be asked to write down any changes they notice in their diaries. In the research, quantitative data will be evaluated with descriptive statistical tests, and qualitative data will be evaluated with content analysis, descriptive and thematic analysis. As a result of the research, it is aimed to improve the mindful eating of the participants. It is anticipated that the research will increase the mindfulness level of the participants in their lives and contribute to future research.

Detailed description: This research was planned in an action research design to examine the effect of mindfulness-based training program on individuals' mindful eating in bariatric surgery patients. As an action in the research, an mindfullness-based training program will be developed for the bariatric patient group. Then, in the preoperative period, a four-week, weekly session of mindfulness-based exercise and eating training will be given to the action group as an intervention. Mindful Eating Questionnaire will be applied to all participants (action and control group) before the training, and data will be collected from the action group with the vignette technique. A short cut story will be prepared, and the participants will be asked to complete the short story in written form. At the end of the training sessions, a focus group discussion will be held with the participants. An in-depth interview will be conducted with each participant in line with the semi-structured interview form in the third and sixth months after the surgery. The Mindful Eating Questionnaire will be readministered to both the action group and the control group. During and after the training, participants will be asked to write down any changes they notice in their diaries. In the research, quantitative data will be evaluated with descriptive statistical tests, and qualitative data will be evaluated with content analysis, descriptive and thematic analysis. As a result of the research, it is aimed to improve the mindful eating of the participants. It is anticipated that the research will increase the mindfulness level of the participants in their lives and contribute to future research.

In this research, the training program was designed as an intervention. The training program consists of preparation, implementation, follow-up, and evaluation phases. The implementation plan of the research is summarized below:

PREPARATION PHASE Preparation of Mindfulness-based training program in bariatric surgery Inviting adult individuals to participate in research before bariatric surgery and reaching the targeted number of participants.

* Participants who agreed to participate in the study should fill out the individual introduction form, complete the cut short story, and apply the Mindful Eating Questionnaire to the participants.
* Application of the Mindful Eating Questionnaire to the Control Group

ACTION

* Conducting mindfulness-based 4-session training program
* Focus group discussion after the training

FOLLOW-UP PHASE (3rd MONTH/6.MONTH POSTOPERATIVE)

* Reminder of weekly practices
* Recording changes in mindful eating in participant experience diaries during the follow-up

DATA COLLECTION

* Individual in-depth interviews with each of the participants in the action group at the end of the follow-up phase (3rd and 6th months)
* At the end of the follow-up period, re-administration of the Mindful Eating Questionnaire to both the action and control groups (3rd and 6th months)

Eligibility criteria: Inclusion Criteria:

* People who agreed to participate in the research.
* Being included in the bariatric surgery list
* Over 18 years of age old
* Able to understand, speak and write Turkish.
* No cognitive problem in self-expression
* To be able to use the WhatsApp application effectively.
* Absence of alcohol or substance abuse
* No diagnosed psychotic and depressive disorder

Exclusion Criteria:

* Declaring that he will not continue the research at any stage of the research
* Not participating in the entire training program.

Primary outcomes:
measure: Mindful Eating
timeFrame: Before the surgery, 3. and 6. Months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
state: Konyaalti
Study officials:
affiliation: Akdeniz University
name: Defne Dizlek Bayraktar
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Emine Catal
role: STUDY_CHAIR
affiliation: Antalya Training and Research Hospital
name: Huseyin Ciyiltepe
role: STUDY_DIRECTOR
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