Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Rabin Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Rabin Medical Center
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00763126
First received: September 28, 2008
Last updated: September 29, 2008
Last verified: September 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Labor Pain |
Behavioral: stress level |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
Further study details as provided by Rabin Medical Center:
Primary Outcome Measures:
- Stress levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- hemodynamic parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Spouse present, |
Behavioral: stress level
Stress levels
|
| Active Comparator: spouse absent |
Behavioral: stress level
Stress levels
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy term parturients
Exclusion Criteria:
- Diabetes
- Preterm labor
- Mouth pathologies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763126
Contacts
| Contact: Sharon Orbach-Zinger, M.D | 039376811 | sharonorbach@yahoo.com |
Locations
| Israel | |
| Rabin Medical Center | |
| Petach Tikvah, Israel | |
Sponsors and Collaborators
Rabin Medical Center
Investigators
| Principal Investigator: | Sharon Orbach-Zinger | Rabin Medical Center |
More Information
No publications provided
| Responsible Party: | Sharon Orbach-Zinger, M.D, Anesthesiology department |
| ClinicalTrials.gov Identifier: | NCT00763126 History of Changes |
| Other Study ID Numbers: | 5053 |
| Study First Received: | September 28, 2008 |
| Last Updated: | September 29, 2008 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Rabin Medical Center:
|
parturient epidural analgesia labor |
spouse Stress levels Salivary amylase |
Additional relevant MeSH terms:
|
Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013