The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Analgesia; Anxiety; Cesarean Section Complications
• Intervention / Treatment: Behavioral: pre-prepared video describing the cesarean surgery; Behavioral: general information

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: eyal rom, MD; Phone Number: 972546747434; Email: eyalro@cllait.org.il

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Haemek Medical Center
    • Contact: eyal rom, MD; Phone Number: 9726747434; Email: eyalro@clalit.org.il
    • Contact: Sivan Witzman; Phone Number: 972-4-6495348; Email: sivan_we@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: women watching the pre-prepared video before surgery; 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	Behavioral: pre-prepared video describing the cesarean surgery; 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
Placebo Comparator: women not watching the pre-prepared video before surgery; 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.	Behavioral: general information; In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 points: before watching the movie (t1), one hour before surgery (t2), 8 hours after the surgery (t3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal complications	any obstetrical complication	during the time of hospitalization after delivery, up to 1 month
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.	2 points: the morning before surgery (c1) and 6 hours following the surgery (c2)
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.	3 points: before watching the movie (t1), one hour before the surgery (t2), 8 hours after the surgery (t3).

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: eyal rom, MD, Emek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: EMC-19-130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No