Informative Video to Alleviate Anxiety and Improve Satisfaction in Elective Caesarean Section
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Malaya
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All obstetric patients American Society of Anaesthesiologists (ASA) II-III
First time undergo elective caesarean section
Under spinal anaesthesia.
Disqualifiers
Less than 18 years old
ASA IV
known antenatal diagnosis of morbid foetal conditions
history of psychiatry illness
Trial design
Design model
Parallel
Treatments tested in this trial
Informative Video on Perioperative Anxiety and Maternal Satisfaction
BehavioralAn 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Group V ( Informative Video )Experimental treatment 1 intervention
Group B: Group C ( Control Group )No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Perioperative Anxiety Level
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.
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.Secondary outcomes
1
Maternal Satisfaction with Anesthesia and Procedure
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.
Time frame
Postoperative: Maternal satisfaction is assessed on day 1 post-caesarean section, during the same time frame as the anxiety reassessment.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: