Pain at ChildbirthNCT00917332
Effects of Relaxation and Guided Imagery Training on Pain at Childbirth
A study testing relaxation (breathing and muscles) and guided imagery ("safe place") in people with Pain at Childbirth, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain. 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
- Pain at Childbirth
- What is being tested?
- relaxation (breathing and muscles) and guided imagery ("safe place")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Nov 2009
- 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
- women who carry their first child
- women that carry only one embryo
- women who speaks hebrew
Who cannot join
- women who experienced complications in pregnancy.
- women who planning on having an elective Caesarean section.
- women who suffer from background systematic condition (such as high-BP, diabetes).
- women who have psychiatric background.
- women who take chronic medication that might effect childbirth, woman or baby's health.
Trial locations and contacts
1 site in 1 country.
efrat esterkin, MA contact
Israel1 site
Hadassah Ein-Kerem Haspitol
Jerusalem
efrat esterkin, MA, efratkin@gmail.com
efrat esterkin, MA
About this study
Official title: Effects of Relaxation and Guided Imagery Training on Rate and Time of Receiving Regional Anesthesia (Epidural), and on the Experience of Childbirth
The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.
- Conditions
- Pain at Childbirth
- Being tested
- relaxation (breathing and muscles) and guided imagery ("safe place")
- Keywords
- pain, childbirth, relaxation, guided imagery, VAS, epidural
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation (breathing and muscles) and guided imagery ("safe place")Behavioural
intervention group: daily practice of relaxation and guided imagery CD, for a rew weeks, until childbirth.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 55 third trimester women will receive a CD of relaxation and guided imagery (of "safe place"), to practice daily at home until childbirth Receives: Behavioral: relaxation (breathing and muscles) and guided imagery ("safe place") |
| control | No intervention | 55 third trimester women who does not receive the relaxation and guided imagery CD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rating of pain experienced during childbirth on pain VAS
Measured: one time - during hospitalization after childbirth
Secondary outcomes (1)
rate and the starting time of receiving regional anesthesia (epidural)
Measured: at childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain at ChildbirthStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- david mankuta, MD, Principal investigator, hadassah ein-kerem - obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917332
- Sponsor's protocol ID
- 0256-09-HMO
- Status last verified
- Jun 2009
- First submitted
- 8 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Relaxation and Guided Imagery Training on Rate and Time of Receiving Regional Anesthesia (Epidural), and on the Experience of Childbirth
- ClinicalTrials.gov ID
- NCT00917332
- Acronym / sponsor ID
- 0256-09-HMO
- Conditions
- Pain at Childbirth
- Keywords
- pain, childbirth, relaxation, guided imagery, VAS, epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 10 Jun 2009 (estimated)
- 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 purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: relaxation (breathing and muscles) and guided imagery ("safe place")55 third trimester women will receive a CD of relaxation and guided imagery (of "safe place"), to practice daily at home until childbirth |
| control | No intervention | –55 third trimester women who does not receive the relaxation and guided imagery CD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women who carry their first child
- women that carry only one embryo
- women who speaks hebrew
Key exclusion criteria (5 listed)
- women who experienced complications in pregnancy.
- women who planning on having an elective Caesarean section.
- women who suffer from background systematic condition (such as high-BP, diabetes).
- women who have psychiatric background.
- women who take chronic medication that might effect childbirth, woman or baby's health.
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 |
|---|---|---|
| relaxation (breathing and muscles) and guided imagery ("safe place")intervention group: daily practice of relaxation and guided imagery CD, for a rew weeks, until childbirth. | Behavioural | intervention |
Primary outcome
rating of pain experienced during childbirth on pain VAS
Time frame: one time - during hospitalization after childbirth
1 secondary outcome
rate and the starting time of receiving regional anesthesia (epidural)
Time frame: at childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
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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.
efrat esterkin, MA contact
david mankuta, MD principal investigator
hadassah ein-kerem - obstetrics and gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation (breathing and muscles) and guided imagery ("safe place") in people with Pain at Childbirth, run by Hadassah Medical Organization 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 3 inclusion and 5 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 10 Jun 2009. 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. 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 efrat esterkin, MA (efratkin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rating of pain experienced during childbirth on pain VAS (time frame: one time - during hospitalization after childbirth). 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 10 Jun 2009; AzTrials last refreshed its copy on 7 Nov 2026.