AnxietyNCT04177966
The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
A study testing pre-prepared video describing the cesarean surgery and general information in people with Anxiety and Cesarean Section Complications, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Cesarean Section Complications, Pain, Postoperative
- What is being tested?
- pre-prepared video describing the cesarean surgery and general information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First cesarean surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical Center
Afula
eyal rom, MD, 9726747434, eyalro@clalit.org.il
Sivan Witzman, 972-4-6495348, sivan_we@clalit.org.il
About this study
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
Read the 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
- Being tested
- pre-prepared video describing the cesarean surgery, general information
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-prepared video describing the cesarean surgeryBehavioural
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
general informationBehavioural
In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: general information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 points: before watching the movie (t1), one hour before surgery (t2), 8 hours after the surgery (t3).
Secondary outcomes (3)
Maternal complications
any obstetrical complication
Measured: during the time of hospitalization after delivery, up to 1 month
Change from baseline biochemical anxiety level at 6 hours interval following the surgery
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.
Measured: 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.
Measured: 3 points: before watching the movie (t1), one hour before the surgery (t2), 8 hours after the surgery (t3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start29 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Rom, MD, HaEmek Medical Center, Israel
- Investigators
- eyal rom, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177966
- Sponsor's protocol ID
- EMC-19-130
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
- ClinicalTrials.gov ID
- NCT04177966
- Acronym / sponsor ID
- EMC-19-130
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| women watching the pre-prepared video before surgery | Experimental | Behavioral: pre-prepared video describing the cesarean surgeryWomen 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 | Behavioral: general informationWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First cesarean surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-prepared video describing the cesarean surgerya 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 | Behavioural | women watching the pre-prepared video before surgery |
| general informationIn the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film. | Behavioural | women not watching the pre-prepared video before surgery |
Primary outcome
The difference in anxiety level between the two groups at one hour before surgery.
Time frame: 3 points: before watching the movie (t1), one hour before surgery (t2), 8 hours after the surgery (t3).
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 secondary outcomes
Maternal complications
Time frame: during the time of hospitalization after delivery, up to 1 month
Change from baseline biochemical anxiety level at 6 hours interval following the surgery
Time frame: 2 points: the morning before surgery (c1) and 6 hours following the surgery (c2)
Change from baseline pain level at 8 hours after surgery
Time frame: 3 points: before watching the movie (t1), one hour before the surgery (t2), 8 hours after the surgery (t3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eyal rom, MD principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-prepared video describing the cesarean surgery and general information in people with Anxiety and Cesarean Section Complications, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eyal rom, MD (972546747434, eyalro@cllait.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in anxiety level between the two groups at one hour before surgery. (time frame: 3 points: before watching the movie (t1), one hour before surgery (t2), 8 hours after the surgery (t3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.