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

NCT04177966 | Unknown

• 1 other identifier: EMC-19-130
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety; Cesarean Section Complications; Pain, Postoperative; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maternal complications

  during the time of hospitalization after delivery, up to 1 month

• Change from baseline biochemical anxiety level at 6 hours interval following the surgery

  2 points: the morning before surgery (c1) and 6 hours following the surgery (c2)

• Change from baseline pain level at 8 hours after surgery

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

Study Arms (2)

women watching the pre-prepared video before surgery

EXPERIMENTAL

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

women not watching the pre-prepared video before surgery

PLACEBO COMPARATOR

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

Interventions

pre-prepared video describing the cesarean surgery BEHAVIORAL

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

women watching the pre-prepared video before surgery

general information BEHAVIORAL

In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.

women not watching the pre-prepared video before surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First cesarean surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• eyal rom, MD

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eyal rom, MD

CONTACT

972546747434; eyalro@cllait.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: July 29, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

IL (1)