Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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). |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| eyal rom, MD | Contact | 972546747434 | eyalro@cllait.org.il |
| Name | Affiliation | Role |
|---|---|---|
| eyal rom, MD | Emek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Medical Center | Recruiting | Afula | Israel |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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
Not provided
Not provided
Not provided
|
| 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. |
|
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). |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |