The Effects of an Information Video on Anxiety and Bariatric Surgery Knowledge Among Bariatric Surgery Candidates

An interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery.In addition, 20 participants will be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidates
• Intervention / Treatment: Behavioral: An information video

Detailed Description

Only few studies have investigated anxiety level, bariatric surgery and nutrition knowledge and weight loss expectations prior to bariatric surgery. No studies have been published on how preparation lectures prior to bariatric surgery impact on anxiety level and on patients' knowledge. A better preparation process prior to the bariatric surgery may have an impact on higher success rates of bariatric surgeries.

Our study is an interventional prospective study on 200 bariatric surgery candidates from the Assuta Medical Center (AMC). The first 100 patients will be assigned to the control group and the later 100 patients will be assigned to the experimental group. All the participants will receive standard care, and only those participants who will assigned to the experimental group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the surgery date. The videotaped lecture will include information and guidelines of bariatric surgery preparation. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss). All participants will complete Bariatric surgery knowledge questionnaire and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and once again at the pre-surgery clinic which take place 1-10 days pre-surgery. In addition, 20 participants be recruited to a pilot study for the validation of the Bariatric surgery knowledge questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pre-surgery: 18 years old or older, BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities and approval of the AMC committee to undergo bariatric surgery.
• Surgery types: laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB) and Single-anastomosis gastric bypass (SAGB)
• Surgery will take place at Assuta medical center.
• Reading and speaking Hebrew.

Exclusion Criteria:

• Previous bariatric surgery.
• Surgery types: laparoscopic adjustable gastric band (LAGB) or biliopancreatic diversion with duodenal switch (BPD-DS)
• Less than 2 weeks between bariatric committee and surgery date

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; Participants who will assigned to the experimental group will be asked to watch an information video of 30 minutes 1-2 weeks prior to the surgery date. n=100.	Behavioral: An information video; Participants who will assigned to the experimental group will be asked to watch a 30 minutes videotaped lecture 1-2 weeks prior to the surgery date. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss).
No Intervention: The control group; Participants who will assigned to the control group will receive standard care and will not asked to watch a videotaped lecture prior to the surgery. n=100.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Pre-surgery anxiety level will be measured by the state-trait anxiety inventory (STAI) questionnaire.	pre-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bariatric surgery and nutrition knowledge	Bariatric surgery and nutrition knowledge will be measured by a questionnaire written by investigators.	pre-surgery
Weight loss expectation		pre-surgery

Collaborators and Investigators

• Sponsor: Assuta Medical Center

Publications and helpful links

General Publications

• Sherf-Dagan S, Hod K, Mardy-Tilbor L, Gliksman S, Ben-Porat T, Sakran N, Zelber-Sagi S, Goitein D, Raziel A. The Effect of Pre-Surgery Information Online Lecture on Nutrition Knowledge and Anxiety Among Bariatric Surgery Candidates. Obes Surg. 2018 Jul;28(7):1876-1885. doi: 10.1007/s11695-018-3134-y.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; Bariatric surgery; Nutrition knowledge; Weight loss expectations
• Other Study ID Numbers: 0041-16