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

NCT ID: NCT04177966

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2023-12-31

Brief Summary

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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

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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

Conditions

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Anxiety Cesarean Section Complications Pain, Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

pre-prepared video describing the cesarean surgery

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

general information

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Eyal Rom, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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eyal rom, MD

Role: PRINCIPAL_INVESTIGATOR

Emek Medical Center

Locations

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Haemek Medical Center

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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eyal rom, MD

Role: CONTACT

972546747434

Facility Contacts

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eyal rom, MD

Role: primary

9726747434

Sivan Witzman

Role: backup

972-4-6495348

Other Identifiers

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EMC-19-130

Identifier Type: -

Identifier Source: org_study_id

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