The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
Primary Purpose
Anxiety, Cesarean Section Complications, Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
pre-prepared video describing the cesarean surgery
general information
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- First cesarean surgery
Exclusion Criteria:
- Women who have had surgery beyond age 2 years
- Women with anxiety disorders
- Women with comorbidity that might alter cortisol and catecholamine excretion,
- Women with comorbidity associated with severe pain that might distort pain ratings
- Women with psychiatric comorbidity that might reduce the ability to understand the videotape and questionnaires
- Women who consume any medication that might affect urinary excretion of cortisol
- Women undergoing cesarean surgery due to obstetric complication (gestational hypertension, pre-eclampsia, gestational diabetes mellitus)
Sites / Locations
- Haemek Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
women watching the pre-prepared video before surgery
women not watching the pre-prepared video before surgery
Arm Description
Women undergoing primary elective cesarean surgery at term The day before surgery the women will watch a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation
Women undergoing primary elective cesarean surgery at term Women will receive general information about the surgery as part of informed consent, without watching a pre- prepared film.
Outcomes
Primary Outcome Measures
The difference in anxiety level between the two groups at one hour before surgery.
To assess a patient's anxiety response to a given situation, the investigators will use State Trait Anxiety Scale (STAI) questionnaire. The questionnaire consists of two sets of 20 different questions that can be answered from 1 to 4. The first (state subscale) assesses a current anxiety condition, while the second (trait subscale) assesses personality characteristics.
This questionnaire was found to be valid for use in a study of a pregnant women population. High scores indicate high levels of anxiety Although the outcome is the The difference in anxiety level between the two groups at one hour before surgery, the investigators will assess the baseline anxiety level and 8 hours after the surgery, for inter-group comparison.
Secondary Outcome Measures
Maternal complications
any obstetrical complication
Change from baseline biochemical anxiety level at 6 hours interval following the surgery
Cortisol blood levels taken 6 hours following the surgery. Although the outcome is the change from baseline level at 6 hours following the surgery, the investigators will assess the cortisol level 6 hours after the surgery for inter-group comparison.
Change from baseline pain level at 8 hours after surgery
To assess a patient's pain level, the investigators will use visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). a lower pain level 8 hours after surgery is a better outcome Although the outcome is the change from baseline level at 8 hours after the surgery, the investigators will assess the pain level before the surgery for inter-group comparison.
Full Information
NCT ID
NCT04177966
First Posted
November 21, 2019
Last Updated
February 28, 2023
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT04177966
Brief Title
The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
Official Title
The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aim is to examine the relationship between providing information to women prior to elective cesarean delivery and anxiety levels around surgery.
the patients will be assigned into two groups - intervention and control. In the intervention group - the day before surgery the women will watch a pre-prepared video showing in detail the course of events around the operation.
the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups
Detailed Description
Women will be recruited for research at the time of admission preoperatively. According to randomization women will be divided into two groups - intervention and control In the intervention group - the day before surgery the women will watch a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating room, anesthesia procedure, surgery Itself, post-operative recovery and recovery course in maternity ward.
The movie will be shown to the patient by one of the study investigators. In the control group - women will receive general information about the surgery as part of the routine informed consent process, without watching a pre- prepared film.
the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Cesarean Section Complications, Pain, Postoperative, Analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Women will be recruited for research at the time of admission preoperatively According to randomization women will be divided into two groups - intervention and control
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
women watching the pre-prepared video before surgery
Arm Type
Experimental
Arm Description
Women undergoing primary elective cesarean surgery at term The day before surgery the women will watch a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation
Arm Title
women not watching the pre-prepared video before surgery
Arm Type
Placebo Comparator
Arm Description
Women undergoing primary elective cesarean surgery at term Women will receive general information about the surgery as part of informed consent, without watching a pre- prepared film.
Intervention Type
Behavioral
Intervention Name(s)
pre-prepared video describing the cesarean surgery
Intervention Description
a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating r
Intervention Type
Behavioral
Intervention Name(s)
general information
Intervention Description
In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.
Primary Outcome Measure Information:
Title
The difference in anxiety level between the two groups at one hour before surgery.
Description
To assess a patient's anxiety response to a given situation, the investigators will use State Trait Anxiety Scale (STAI) questionnaire. The questionnaire consists of two sets of 20 different questions that can be answered from 1 to 4. The first (state subscale) assesses a current anxiety condition, while the second (trait subscale) assesses personality characteristics.
This questionnaire was found to be valid for use in a study of a pregnant women population. High scores indicate high levels of anxiety Although the outcome is the The difference in anxiety level between the two groups at one hour before surgery, the investigators will assess the baseline anxiety level and 8 hours after the surgery, for inter-group comparison.
Time Frame
3 points: before watching the movie (t1), one hour before surgery (t2), 8 hours after the surgery (t3).
Secondary Outcome Measure Information:
Title
Maternal complications
Description
any obstetrical complication
Time Frame
during the time of hospitalization after delivery, up to 1 month
Title
Change from baseline biochemical anxiety level at 6 hours interval following the surgery
Description
Cortisol blood levels taken 6 hours following the surgery. Although the outcome is the change from baseline level at 6 hours following the surgery, the investigators will assess the cortisol level 6 hours after the surgery for inter-group comparison.
Time Frame
2 points: the morning before surgery (c1) and 6 hours following the surgery (c2)
Title
Change from baseline pain level at 8 hours after surgery
Description
To assess a patient's pain level, the investigators will use visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). a lower pain level 8 hours after surgery is a better outcome Although the outcome is the change from baseline level at 8 hours after the surgery, the investigators will assess the pain level before the surgery for inter-group comparison.
Time Frame
3 points: before watching the movie (t1), one hour before the surgery (t2), 8 hours after the surgery (t3).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First cesarean surgery
Exclusion Criteria:
Women who have had surgery beyond age 2 years
Women with anxiety disorders
Women with comorbidity that might alter cortisol and catecholamine excretion,
Women with comorbidity associated with severe pain that might distort pain ratings
Women with psychiatric comorbidity that might reduce the ability to understand the videotape and questionnaires
Women who consume any medication that might affect urinary excretion of cortisol
Women undergoing cesarean surgery due to obstetric complication (gestational hypertension, pre-eclampsia, gestational diabetes mellitus)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eyal rom, MD
Phone
972546747434
Email
eyalro@cllait.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eyal rom, MD
Organizational Affiliation
Emek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eyal rom, MD
Phone
9726747434
Email
eyalro@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Sivan Witzman
Phone
972-4-6495348
Email
sivan_we@clalit.org.il
12. IPD Sharing Statement
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The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
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