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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06545019
Enrollment
75
Registered
2024-08-09
Start date
2024-08-15
Completion date
2025-06-15
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-operative Anxiety, Satisfaction, Patient, Spinal Anesthesia

Keywords

Informative Video, Perioperative Alleviation of Anxiety, Maternal Satisfaction, Preoperative Education, Elective Cesarean Section, Spinal Anesthesia

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.

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.

Interventions

BEHAVIORALInformative 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.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

The parturient will be randomly grouped into two groups which are Group V (Informative Video) and Group C (control group) using a computer-generated sequence in a permuted block of six. A research assistant/medical officer who is not involved in the conduct of study will perform the allocation concealment by placing the randomization sequence into sealed and opaque envelopes, which will be numbered accordingly. The next available envelope will be taken for the next recruited parturient and open by the investigator after the baseline anxiety level assessment is completed.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative Anxiety LevelPreoperative: 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.

Secondary

MeasureTime frameDescription
Maternal Satisfaction with Anesthesia and ProcedurePostoperative: 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.

Contacts

Primary ContactKamarrudin Hadri, MBBS
hadrikamarrudin@gmail.com+60149662077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026