Informative Video to Alleviate Anxiety and Improve Satisfaction in Elective Caesarean Section
NCT ID: NCT06545019
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2024-08-15
2025-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
"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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
NCT04177966
Placebo Versus Nocebo: Effects on Pain and Anxiety During Local Anaesthetic Infiltration in Parturient Undergoing Elective Caesarean Delivery
NCT04975659
Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery
NCT06708169
A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
NCT06945250
A 5-Year Anesthetic Evaluation of Cases Undergoing Cesarean Section Delivery ın Our Clinic
NCT06524713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 .
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.
Group C ( Control Group )
Will not receive the informative video . During day of surgery , will receive standard care as per protocols .
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* First time undergo elective caesarean section
* Under spinal anaesthesia.
Exclusion Criteria
* ASA IV
* known antenatal diagnosis of morbid foetal conditions
* history of psychiatry illness
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Malaya
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Hadri Kamarrudin
Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kamarrudin Hadri, MBBS
Role: STUDY_DIRECTOR
University of Malaya
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Chan YK, Ng KP. A survey of the current practice of obstetric anaesthesia and analgesia in Malaysia [correction of Malaysis]. J Obstet Gynaecol Res. 2000 Apr;26(2):137-40. doi: 10.1111/j.1447-0756.2000.tb01297.x.
Jiang A, Perry T, Walker K, Burfoot A, Patterson L. Surgical sensation during caesarean section: a qualitative analysis. Int J Obstet Anesth. 2024 Feb;57:103935. doi: 10.1016/j.ijoa.2023.103935. Epub 2023 Nov 3.
Vogel TM, Homitsky S. Antepartum and intrapartum risk factors and the impact of PTSD on mother and child. BJA Educ. 2020 Mar;20(3):89-95. doi: 10.1016/j.bjae.2019.11.005. Epub 2020 Jan 28. No abstract available.
Vogel H, Schaaf W, Jacob M. [Video-assisted patient education in anesthesia : How do medical users assess the procedure?]. Anaesthesist. 2018 Nov;67(11):829-836. doi: 10.1007/s00101-018-0496-4. Epub 2018 Oct 9. German.
Maghalian M, Mohammad-Alizadeh-Charandabi S, Ranjbar M, Alamdary FA, Mirghafourvand M. Informational video on preoperative anxiety and postoperative satisfaction prior to elective cesarean delivery: a systematic review and meta-analysis. BMC Psychol. 2024 Jan 2;12(1):6. doi: 10.1186/s40359-023-01499-3.
Lin SY, Huang HA, Lin SC, Huang YT, Wang KY, Shi HY. The effect of an anaesthetic patient information video on perioperative anxiety: A randomised study. Eur J Anaesthesiol. 2016 Feb;33(2):134-9. doi: 10.1097/EJA.0000000000000307.
Che YJ, Gao YL, Jing J, Kuang Y, Zhang M. Effects of an Informational Video About Anesthesia on Pre- and Post-Elective Cesarean Section Anxiety and Recovery: A Randomized Controlled Trial. Med Sci Monit. 2020 Apr 8;26:e920428. doi: 10.12659/MSM.920428.
Singh K, Heralal H. The Effect of a Simple Perioperative Video on Maternal Anxiety and Satisfaction Before Regional Anesthesia in a Caribbean Setting: A Randomized Controlled Trial. Cureus. 2023 Mar 21;15(3):e36482. doi: 10.7759/cureus.36482. eCollection 2023 Mar.
Abate, S. M., Chekol, Y. A., & Basu, B. (2020). Global prevalence and determinants of preoperative anxiety among surgical patients: A systematic review and meta-analysis. International Journal of Surgery Open, 25, 6-16
Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.
Bansal T, Joon A. A comparative study to assess preoperative anxiety in obstetric patients undergoing elective or emergency cesarean section. Anaesth Pain Intensive Care 2019:25e30.
Fentie Y, Yetneberk T, Gelaw M. Preoperative anxiety and its associated factors among women undergoing elective caesarean delivery: a cross-sectional study. BMC Pregnancy Childbirth. 2022 Aug 17;22(1):648. doi: 10.1186/s12884-022-04979-3.
Mitchell M. Conscious surgery: influence of the environment on patient anxiety. J Adv Nurs. 2008 Nov;64(3):261-71. doi: 10.1111/j.1365-2648.2008.04769.x. Epub 2008 Sep 10.
Matthey PW, Finegan BA, Finucane BT. The public's fears about and perceptions of regional anesthesia. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):96-101. doi: 10.1016/j.rapm.2003.10.017.
Snyder-Ramos SA, Seintsch H, Bottiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.
Yılmaz, G., Akça, A., Esen, O., & Salihoğlu, Z. (2019). Multimedia education on the day of elective cesarean section increases anxiety scores. Perinatal Journal, 27(1), 38-42.
Noben L, Goossens SMTA, Truijens SEM, van Berckel MMG, Perquin CW, Slooter GD, van Rooijen SJ. A Virtual Reality Video to Improve Information Provision and Reduce Anxiety Before Cesarean Delivery: Randomized Controlled Trial. JMIR Ment Health. 2019 Dec 18;6(12):e15872. doi: 10.2196/15872.
Kanyeki T, Mung'ayi V, Bal R, Odaba D. Effect of video-based information on preoperative State trait anxiety inventory scores in adult patients presenting for elective caesarean section: a randomized controlled trial. Afr Health Sci. 2022 Sep;22(3):117-124. doi: 10.4314/ahs.v22i3.14.
Eley VA, Searles T, Donovan K, Walters E. Effect of an anaesthesia information video on preoperative maternal anxiety and postoperative satisfaction in elective caesarean section: a prospective randomised trial. Anaesth Intensive Care. 2013 Nov;41(6):774-81. doi: 10.1177/0310057X1304100613.
Fisher PL, Durham RC. Recovery rates in generalized anxiety disorder following psychological therapy: an analysis of clinically significant change in the STAI-T across outcome studies since 1990. Psychol Med. 1999 Nov;29(6):1425-34. doi: 10.1017/s0033291799001336.
Spielberger C, Gorsuch R, Lushene R: State-trait anxiety inventory for adults sampler set: Manual, instrument and scoring guide. Consulting Psychologists Press, 1983
Embong, H. (2018). Psychometric Properties of the Malay Translated Spielberger State-Trait Anxiety Inventory in Exploring Parental Anxiety. Medicine & Health, 13(1), 106-116.
Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202459-13718
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.