Labor PainNCT00763126
Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
A study testing stress level in people with Labor Pain, run by Rabin Medical Center at 1 site in Israel.
Trial summary
It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress level during the performance of epidural analgesia during labor. Couples will be randomized to two groups: one group where the spouse is present during the performance of epidural analgesia and the second where the spouse is… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- stress level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Oct 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy term parturients
Who cannot join
- Diabetes
- Preterm labor
- Mouth pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Presence of a Spouse on the Parturient's and Her Spouse's Stress Level During Epidural Analgesia During Labor as Measured by Salivary Amylase
It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress level during the performance of epidural analgesia during labor.
Couples will be randomized to two groups: one group where the spouse is present during the performance of epidural analgesia and the second where the spouse is not present.
Before and after epidural anlgesia, both the spouse and parturient will be have their blood pressure and pulse checked. In addition, both will have their salivary amylase measured.
Salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. To check this enzyme, a sample of saliva is given.
- Conditions
- Labor Pain
- Being tested
- stress level
- Keywords
- parturient, epidural analgesia, labor, spouse, Stress levels, Salivary amylase
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress levelBehavioural
Stress levels
| Study group | Role | What they receive |
|---|---|---|
| Spouse present, | Active comparator | Not described Receives: Behavioral: stress level |
| spouse absent | Active comparator | Not described Receives: Behavioral: stress level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress levels
Measured: 1 year
Secondary outcomes (1)
hemodynamic parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sharon Orbach-Zinger, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763126
- Sponsor's protocol ID
- 5053
- Status last verified
- Sep 2008
- First submitted
- 28 Sep 2008
- Last updated
- 30 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Presence of a Spouse on the Parturient's and Her Spouse's Stress Level During Epidural Analgesia During Labor as Measured by Salivary Amylase
- ClinicalTrials.gov ID
- NCT00763126
- Acronym / sponsor ID
- 5053
- Conditions
- Labor Pain
- Keywords
- parturient, epidural analgesia, labor, spouse, Stress levels, Salivary amylase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- First posted
- 30 Sep 2008 (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.
It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress level during the performance of epidural analgesia during labor.
Couples will be randomized to two groups: one group where the spouse is present during the performance of epidural analgesia and the second where the spouse is not present.
Before and after epidural anlgesia, both the spouse and parturient will be have their blood pressure and pulse checked. In addition, both will have their salivary amylase measured.
Salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. To check this enzyme, a sample of saliva is given.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spouse present, | Active comparator | Behavioral: stress level |
| spouse absent | Active comparator | Behavioral: stress level |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy term parturients
Key exclusion criteria (3 listed)
- Diabetes
- Preterm labor
- Mouth pathologies
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 |
|---|---|---|
| stress levelStress levels | Behavioural | Spouse present,, spouse absent |
Primary outcome
Stress levels
Time frame: 1 year
1 secondary outcome
hemodynamic parameters
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2008.
Related trials for Labor Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
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.
Sharon Orbach-Zinger principal investigator
Rabin 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 stress level in people with Labor Pain, run by Rabin Medical Center 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 3 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 30 Sep 2008. 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 Sharon Orbach-Zinger, M.D (039376811, sharonorbach@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress levels (time frame: 1 year). 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 30 Sep 2008.