Informative Video to Alleviate Anxiety and Improve Satisfaction in Elective Caesarean Section (IVAPAS)

August 20, 2024 updated by: Dr Hadri Kamarrudin, University of Malaya

Study of Informative Video On Alleviating Perioperative Anxiety And Improving Satisfaction Score In Obstetric Patient Undergoing Elective Lower Segment Caesarean Section Under Spinal Anaesthesia

Title:

"Study of Informative Video on Alleviating Perioperative Anxiety and Improving Satisfaction Score in Obstetric Patients Undergoing Elective Lower Segment Caesarean Section Under Spinal Anaesthesia"

Objective:

This study aims to evaluate the effectiveness of an informative video in reducing perioperative anxiety and enhancing satisfaction in obstetric patients undergoing elective Caesarean sections under spinal anaesthesia. The hypothesis is that patients who view the video will experience lower anxiety and higher satisfaction compared to those who receive standard pre-anaesthetic counselling alone.

Background:

Spinal anaesthesia, commonly used for Caesarean sections, offers rapid, predictable pain relief but can cause discomfort due to factors such as visceral pain and fundal pressure, leading to perioperative anxiety. Anxiety can negatively impact maternal satisfaction and increase the risk of postpartum complications. Previous studies have shown mixed results regarding the efficacy of educational videos in alleviating this anxiety.

Methods:

The study is a prospective, randomized controlled trial conducted at Universiti Malaya Medical Centre. Eligible participants are obstetric patients (ASA II-III) undergoing elective Caesarean sections. Participants are randomly assigned to either an intervention group, which receives a supplemental informative video, or a control group receiving standard care. Anxiety and satisfaction levels are assessed using validated questionnaires pre- and post-surgery.

Anticipated Outcomes:

The study hypothesizes that the informative video will significantly reduce perioperative anxiety and improve maternal satisfaction, thereby demonstrating the superiority of this intervention over standard pre-anaesthetic counselling.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction Spinal anaesthesia is the preferred method for Caesarean sections due to its high success rate and minimal impact on maternal-fetal physiology. However, it is not without discomfort, as patients remain awake and can experience visceral pain, nausea, and other sensations that contribute to perioperative anxiety and dissatisfaction. This study explores the potential of an informative video to address these issues and improve patient outcomes.

Problem Statement Despite the widespread use of educational videos, the optimal approach for reducing anxiety and improving satisfaction in Caesarean patients remains unclear. Previous videos have focused on technical aspects of spinal anaesthesia without adequately addressing potential discomforts. This study seeks to bridge this gap by emphasizing specific sources of discomfort in the video content.

Research Questions Can an informative video highlighting potential sources of anxiety and dissatisfaction effectively alleviate these issues during the perioperative period? Is the video more effective than standard pre-anaesthetic counselling alone? Hypotheses Null Hypothesis: There is no significant difference in anxiety and satisfaction between patients who view the video and those who do not.

Alternative Hypothesis: Patients who view the video will have lower anxiety and higher satisfaction levels.

Objectives Evaluate if the video effectively reduces perioperative anxiety and dissatisfaction.

Determine if the video outperforms standard counselling in achieving these outcomes.

Methods

Study Design:

A prospective, randomized controlled trial at Universiti Malaya Medical Centre from July 2024 to June 2025.

Participants:

Inclusion Criteria: Obstetric patients ASA II-III undergoing first elective Caesarean section under spinal anaesthesia.

Exclusion Criteria: Patients under 18, ASA IV, diagnosed with morbid fetal conditions, or with psychiatric illness.

Randomization:

Participants are randomly assigned to two groups (Group V: Video, Group C: Control) using a computer-generated sequence. Allocation concealment is ensured through sealed envelopes.

Intervention:

The intervention group receives a QR code to access the informative video on their phones, with no viewing restrictions. The control group receives standard care.

Assessment Tools:

Anxiety: Spielberger State-Trait Anxiety Inventory (STAI), assessing pre- and post-operative anxiety levels.

Satisfaction: Maternal Satisfaction Scale for Caesarean Section (MSSCS), evaluating satisfaction post-surgery.

Sample Size:

A total of 75 participants (31 per group, accounting for a 20% dropout rate) are needed to detect a clinically significant reduction in anxiety.

Data Collection and Analysis Data are collected using standardized forms and questionnaires. Analysis is conducted with IBM SPSS to assess normal distribution and differences between groups. Statistical significance is determined at a p-value < 0.05.

Conclusion The study aims to demonstrate that an informative video addressing specific discomforts associated with spinal anaesthesia can significantly reduce anxiety and improve satisfaction in obstetric patients, offering a potentially superior alternative to standard pre-anaesthetic counselling.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All obstetric patients American Society of Anaesthesiologists (ASA) II-III
  • First time undergo elective caesarean section
  • Under spinal anaesthesia.

Exclusion Criteria:

  • Less than 18 years old
  • ASA IV
  • known antenatal diagnosis of morbid foetal conditions
  • history of psychiatry illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group V ( Informative Video )

Receive QR code of the informative video. Participants can watch it on their phones as many times as they wish.

During day of surgery , will receive standard care as per protocols .
Behavioral: Informative Video on Perioperative Anxiety and Maternal Satisfaction
An informative video designed to address potential sources of perioperative anxiety and dissatisfaction during elective lower segment caesarean section under spinal anaesthesia. The video provides details about the procedure, expected sensations, and management of discomfort to enhance patient understanding and reduce anxiety. It is administered to the intervention group of patients scheduled for elective caesarean section, allowing them to view it on their personal devices before the surgery.
No Intervention: Group C ( Control Group )
Will not receive the informative video . During day of surgery , will receive standard care as per protocols .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Anxiety Level
Time Frame: Preoperative: Baseline anxiety levels are assessed one day before the caesarean section.Postoperative: Anxiety levels are reassessed on day 1 post-caesarean section.
The primary outcome measure is the level of perioperative anxiety experienced by patients, assessed using the Speiberger State-Trait Anxiety Inventory (STAI). This tool evaluates both state and trait anxiety levels, focusing on current anxiety experienced by patients before and after the elective lower segment caesarean section under spinal anaesthesia.
Preoperative: Baseline anxiety levels are assessed one day before the caesarean section.Postoperative: Anxiety levels are reassessed on day 1 post-caesarean section.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Satisfaction with Anesthesia and Procedure
Time Frame: Postoperative: Maternal satisfaction is assessed on day 1 post-caesarean section, during the same time frame as the anxiety reassessment.
The secondary outcome measure is maternal satisfaction, assessed using the Maternal Satisfaction Scale for Caesarean Section (MSSCS). This scale evaluates patients' overall satisfaction with their anaesthetic experience, including procedural comfort and management of any adverse effects.
Postoperative: Maternal satisfaction is assessed on day 1 post-caesarean section, during the same time frame as the anxiety reassessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Director: Kamarrudin Hadri, MBBS, University Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202459-13718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Satisfaction, Patient

Clinical Trials on Informative Video on Perioperative Anxiety and Maternal Satisfaction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe