Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545019
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Informative Video to Alleviate Anxiety and Improve Satisfaction in Elective Caesarean Section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Informative Video On Alleviating Perioperative Anxiety And Improving Satisfaction Score In Obstetric Patient Undergoing Elective Lower Segment Caesarean Section Under Spinal Anaesthesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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
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 005
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
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 005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None