Pre-operative AnxietyNCT06545019
Informative Video to Alleviate Anxiety and Improve Satisfaction in Elective Caesarean Section
A study testing Informative Video on Perioperative Anxiety and Maternal Satisfaction in people with Pre-operative Anxiety and Spinal Anesthesia, run by University of Malaya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-operative Anxiety, Spinal Anesthesia, Satisfaction, Patient
- What is being tested?
- Informative Video on Perioperative Anxiety and Maternal Satisfaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All obstetric patients American Society of Anaesthesiologists (ASA) II-III
- First time undergo elective caesarean section
- Under spinal anaesthesia.
Who cannot join
- Less than 18 years old
- ASA IV
- known antenatal diagnosis of morbid foetal conditions
- history of psychiatry illness
Trial locations and contacts
No sites are listed yet.
About this study
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
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"
Read more
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.
Read the 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.
- Being tested
- Informative Video on Perioperative Anxiety and Maternal Satisfaction
- Keywords
- Informative Video, Perioperative Alleviation of Anxiety, Maternal Satisfaction, Preoperative Education, Elective Cesarean Section, Spinal Anesthesia
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative Video on Perioperative Anxiety and Maternal SatisfactionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group V ( Informative Video ) | Experimental | 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 . Receives: Behavioral: Informative Video on Perioperative Anxiety and Maternal Satisfaction |
| Group C ( Control Group ) | No intervention | Will not receive the informative video . During day of surgery , will receive standard care as per protocols . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative: Maternal satisfaction is assessed on day 1 post-caesarean section, during the same time frame as the anxiety reassessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pre-operative AnxietyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hadri Kamarrudin, University of Malaya
- Investigators
- Kamarrudin Hadri, MBBS, Study director, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545019
- Sponsor's protocol ID
- 202459-13718
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10870307Jiang 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.
PubMed 37925355Vogel 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.
PubMed 33456935Vogel 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.
PubMed 30302517Maghalian 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.
PubMed 38167236Lin 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.
PubMed 26196527Che 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.
PubMed 32265432Singh 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.
PubMed 37090355Abate, 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.
PubMed 34130991Bansal 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.
PubMed 35978308Mitchell 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.
PubMed 18785887Matthey 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.
PubMed 15029543Snyder-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.
PubMed 15920209
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06545019
- Acronym / sponsor ID
- 202459-13718
- Keywords
- Informative Video, Perioperative Alleviation of Anxiety, Maternal Satisfaction, Preoperative Education, Elective Cesarean Section, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group V ( Informative Video ) | Experimental | Behavioral: Informative Video on Perioperative Anxiety and Maternal SatisfactionReceive 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 . |
| Group C ( Control Group ) | No intervention | –Will not receive the informative video . During day of surgery , will receive standard care as per protocols . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All obstetric patients American Society of Anaesthesiologists (ASA) II-III
- First time undergo elective caesarean section
- Under spinal anaesthesia.
Key exclusion criteria (4 listed)
- Less than 18 years old
- ASA IV
- known antenatal diagnosis of morbid foetal conditions
- history of psychiatry illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informative Video on Perioperative Anxiety and Maternal SatisfactionAn 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. | Behavioural | Group V ( Informative Video ) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Results publication: PubMed 10870307Chan 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.
- Results publication: PubMed 37925355Jiang 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.
- Results publication: PubMed 33456935Vogel 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.
- Results publication: PubMed 30302517Vogel 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.
- Results publication: PubMed 38167236Maghalian 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.
- Results publication: PubMed 26196527Lin 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.
- Results publication: PubMed 32265432Che 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.
- Results publication: PubMed 37090355Singh 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.
- Results publicationAbate, 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
- Results publication: PubMed 34130991Betran 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.
- Results publicationBansal 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.
- Results publication: PubMed 35978308Fentie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamarrudin Hadri, MBBS study director
University of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Informative Video on Perioperative Anxiety and Maternal Satisfaction in people with Pre-operative Anxiety and Spinal Anesthesia, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamarrudin Hadri, MBBS (+60149662077, hadrikamarrudin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545019, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.