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

HaEmek Medical Center, Israel

Status: Enrolling

Conditions: Cesarean Section Complications; Pain, Postoperative; Analgesia; Anxiety

Treatments: Behavioral: general information; Behavioral: pre-prepared video describing the cesarean surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04177966

EMC-19-130

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

women watching the pre-prepared video before surgery

Experimental group

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

Treatment:

Behavioral: pre-prepared video describing the cesarean surgery

women not watching the pre-prepared video before surgery

Placebo Comparator group

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.

Treatment:

Behavioral: general information