Cesarean SectionNCT05790954
The Effect of Pre-Cesarean Section Guided Imagery
A study testing Guided imagery in people with Cesarean Section, run by Menekşe Nazlı AKER at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of guided imagery applied before cesarean section on preoperative anxiety, fear and physiological parameters. The study will be carried out in two different groups. The practice will start with meeting the women 3 days before cesarean section. 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
- Cesarean Section
- What is being tested?
- Guided imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2023to 31 May 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
- planned cesarean section
- Single birth
- giving birth at term
- No hearing problems
- Agreeing to participate in the research and obtaining written permission,
Who cannot join
- Emergency cesarean section due to a health problem of the mother or baby
- Not completing the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-Cesarean Section Guided Imagery on Preoperative Anxiety, Fear and Physiological Parameters
The aim of this study is to evaluate the effect of guided imagery applied before cesarean section on preoperative anxiety, fear and physiological parameters.
The study will be carried out in two different groups. The practice will start with meeting the women 3 days before cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out random. The following applications will be made to the groups.
- Conditions
- Cesarean Section
- Being tested
- Guided imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imageryOther
Three days before the cesarean section, the participants will be given a guided imagery audio recording and will be asked to listen to it before going to bed every evening until the day of the cesarean section. On the morning of the cesarean section, after the patient is prepared, the guided imagery audio recording will be played again.
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery Group | Experimental | Not described Receives: Other: Guided imagery |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Measured: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
Change in Surgical Fear
Surgical Fear Questionnaire has been developed to determine the level of fear of patients who will undergo electrical surgery for the short and long -term results of surgical operation. The scale is a scales of 11 Likertes, which consist of 8 items, scored between 0-10. Each item 0 is scored as "I'm at all scared", 10 "I'm very scared". The total score of the scale is 0-80. The high score states that surgical fear is high.
Measured: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
Secondary outcomes (5)
systolic and diastolic blood pressure
mmHg
Measured: Fifteen minutes after preparation for cesarean section
heart rate
beats per minute
Measured: Fifteen minutes after preparation for cesarean section
body temperature
degrees Celsius
Measured: Fifteen minutes after preparation for cesarean section
respiratory rate
beats per minute
Measured: Fifteen minutes after preparation for cesarean section
fetal heart rate
beats per minute
Measured: Fifteen minutes after preparation for cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start27 Mar 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menekşe Nazlı AKER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menekşe Nazlı AKER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790954
- Sponsor's protocol ID
- 15149
- Status last verified
- Feb 2024
- First submitted
- 17 Mar 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Cesarean Section Guided Imagery on Preoperative Anxiety, Fear and Physiological Parameters
- ClinicalTrials.gov ID
- NCT05790954
- Acronym / sponsor ID
- 15149
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menekşe Nazlı AKERUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Mar 2023 (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 aim of this study is to evaluate the effect of guided imagery applied before cesarean section on preoperative anxiety, fear and physiological parameters.
The study will be carried out in two different groups. The practice will start with meeting the women 3 days before cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out random. The following applications will be made to the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided imagery Group | Experimental | Other: Guided imagery |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- planned cesarean section
- Single birth
- giving birth at term
- No hearing problems
- Agreeing to participate in the research and obtaining written permission,
Key exclusion criteria (2 listed)
- Emergency cesarean section due to a health problem of the mother or baby
- Not completing the study
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 |
|---|---|---|
| Guided imageryThree days before the cesarean section, the participants will be given a guided imagery audio recording and will be asked to listen to it before going to bed every evening until the day of the cesarean section. On the morning of the cesarean section, after the patient is prepared, the guided imagery audio recording will be played again. | Other | Guided imagery Group |
Primary outcome
Change in anxiety
Time frame: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Change in Surgical Fear
Time frame: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
Surgical Fear Questionnaire has been developed to determine the level of fear of patients who will undergo electrical surgery for the short and long -term results of surgical operation. The scale is a scales of 11 Likertes, which consist of 8 items, scored between 0-10. Each item 0 is scored as "I'm at all scared", 10 "I'm very scared". The total score of the scale is 0-80. The high score states that surgical fear is high.
5 secondary outcomes
systolic and diastolic blood pressure
Time frame: Fifteen minutes after preparation for cesarean section
heart rate
Time frame: Fifteen minutes after preparation for cesarean section
body temperature
Time frame: Fifteen minutes after preparation for cesarean section
respiratory rate
Time frame: Fifteen minutes after preparation for cesarean section
fetal heart rate
Time frame: Fifteen minutes after preparation for cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery in people with Cesarean Section, run by Menekşe Nazlı AKER at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 Feb 2024. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (time frame: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section). The study lists 2 primary outcomes in all. 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 22 Feb 2024.