Clinical trial NCT04177966: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Cesarean Section Complications
Pain, Postoperative
Analgesia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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

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)

Primary outcomes:
measure: The difference in anxiety level between the two groups at one hour before surgery.
timeFrame: 3 points: before watching the movie (t1), one hour before surgery (t2), 8 hours after the surgery (t3).
Secondary outcomes:
measure: Maternal complications
timeFrame: during the time of hospitalization after delivery, up to 1 month
measure: Change from baseline biochemical anxiety level at 6 hours interval following the surgery
timeFrame: 2 points: the morning before surgery (c1) and 6 hours following the surgery (c2)
measure: Change from baseline pain level at 8 hours after surgery
timeFrame: 3 points: before watching the movie (t1), one hour before the surgery (t2), 8 hours after the surgery (t3).
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: Emek Medical Center
name: eyal rom, MD
role: PRINCIPAL_INVESTIGATOR
References: