MATERIAL AND METHODS

Study Area: 7 Air Force Hospital, Kanpur, 208007

Selection of subjects: The representative population for this study would be patients belonging to any ethnicity, gender or age throughout the country who are referred to or brought to 7 AFH, from both rural as well as urban backgrounds who agree to undergo the study with a signed written informed consent and satisfying following inclusion criteria.

Inclusion Criteria: Adult patient population above 18 years of age who can give consent and requires a surgical procedure for treatment. Major listed procedures will be Laparoscopic Cholecystectomy, Laparoscopic Appendicectomy, Laparoscopic hernia repair, open hernia repair, Hemorrhoidectomy, Anal Fistulectomy.

Exclusion Criteria: 

1. Pediatric patient population below 18 years of age
2. Surgery in case of recurrence of disease
3. Emergency surgeries
4. Patients who are unable to give consent

Sample Size: 500 patients satisfying the above criteria who consent to take part in the study.

Study Design: Randomized controlled trial 

Study Duration: May 2024 to May 2026

Study Methodology: (Plan of Work)

This study is a prospective randomized controlled trial. Prior ethical committee clearance will be taken from hospital ethical committee. Research associates will approach eligible patients using a specific procedure, and then explain the study. If patients agree to participate, written informed consent for the study will be obtained. Patients who agree to participate will be randomly assigned to the multimedia (intervention) group or the conventional informed consent (control) group. Group allocation will be performed by simple randomization and this procedure will be conducted in a concealed manner. After randomization, the participants will be assessed at three different points of time: At admission before consent, pre-operative day 01 after providing information regarding surgery, and post-operative day 10 when the patient comes for first follow-up. After randomization, participants will be interviewed to collect their demographic information, including age, sex, education level, etc. Following the standard informed consent process, patients will be randomized to watch the Multimedia (intervention group) or not (control group). The surgeon will be blinded to the group assignments. To measure patient comprehension a customized questionnaire will be made and the content will be tested with experienced surgeons. It will also be pilot tested at 02 sites before the start of the trial.

Participants in the control group will receive a verbal information from health care provider and a standard written informed consent. Participants will also be given an educational session with their health care provider to discuss concerns and ask questions. The consent form will include information similar to that provided to the intervention group. This will ensure that the same quality of information is delivered to all patients.

Participants in the intervention group will receive verbal information from health care providers, standard written informed consent and informative handouts/ videos in addition to standard informed consent. They will also complete a knowledge measurement tool, pain perception as per VAS at baseline, before the intervention. These participants will be then shown an educational animation video illustrating the procedure, risks, benefits, alternatives, and postoperative care relevant to the surgery. All participants will watch the video on a mobile phone. A research associate will provide assistance, as needed, while participants watch the video, to ensure that they completed the process and that their questions are addressed. Watching the video will take approximately 05 min.

On admission, before any information or knowledge is provided to participants, all patients will complete a baseline knowledge questionnaire, pain perception level on VAS, and the APAIS (Amsterdam Preoperative Anxiety & Information Scale) anxiety scale.  Knowledge questionnaire and the anxiety levels will be  again assessed on a day prior to surgery period after providing the information to patients in two different groups. In the immediate post op period on POD 01 pain perception will be checked by VAS and 10 days after recruitment, patients will complete the knowledge questionnaire a third time to assess knowledge retention and risk recall. Patient satisfaction survey will also be carried out at POD 10 which will include answering questions using a five-point Likert scale, to evaluate their satisfaction with the informed consent process.

Also various factors which affects patient understanding about the disease will be evaluated. In our department, the surgical specialists and final year surgical residents are the health care providers responsible for obtaining informed consent for the surgery. Residents obtaining informed consent will be blinded to the knowledge measurement results, and the research associate who will assess the outcomes will be blinded to the interventions.

Outcome will be measured by:

1.     Knowledge Questionnaire
2. II.     Patient Survey
3. III.    Amsterdam Preoperative Anxiety & Information Scale for Anxiety
4. IV.    Risk Recall in post op period
5. V.     Pain perception by Visual Analogue Scale

Data Collection Method

A pretested self-reporting questionnaire along with a Proforma with relevant history and findings will be used to collect relevant information from the patient. The primary outcome will be determined by quantitative scores from 0% to 100%, representing patients’ understanding of the procedure, benefits, risks, alternatives, and postoperative care. Questions are in multiple-choice formats and quantitative scores on the written test will be calculated. Secondary outcomes are evaluated using a five-point Likert ordinal satisfaction scale to represent patient satisfaction with the informed consent process. The frequency of refusal to provide consent will also be recorded.  APAIS will be used for anxiety and VAS for pain perception.

Data collected from participants will be recorded by participant number, with no specific individual identifying information. This method will be followed to protect patient privacy and ensure patient confidentiality. Descriptive statistics will be used to analyze the baseline characteristics of the control and intervention groups. Mean and standard deviations (SD) will be calculated for continuous variables, if normally distributed, and proportions will be calculated for categorical variables. Fisher’s exact test will be performed for binary, ordinal, and categorical variables. Mean scores on the knowledge measurement tool before and after the educational sessions and also between the two groups will be compared using the Student’s t-test between each group and the paired t-test within each group. Differences in knowledge scores will be calculated by subtracting values obtained before the education session from those after the education session. 

A threshold of p values less than 0.05 will be determined for variables as to whether they are considered significant, and 95% CI computed. All data analyses will be conducted using Stata version 10.0 (Stata Corp LP, College Station, TX, USA).