Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
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|ClinicalTrials.gov Identifier: NCT00763126|
Recruitment Status : Unknown
Verified September 2008 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 30, 2008
Last Update Posted : September 30, 2008
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 or disease||Intervention/treatment||Phase|
|Labor Pain||Behavioral: stress level||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||October 2009|
|Active Comparator: Spouse present,||
Behavioral: stress level
|Active Comparator: spouse absent||
Behavioral: stress level
- Stress levels [ Time Frame: 1 year ]
- hemodynamic parameters [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763126
|Contact: Sharon Orbach-Zinger, M.Dfirstname.lastname@example.org|
|Rabin Medical Center|
|Petach Tikvah, Israel|
|Principal Investigator:||Sharon Orbach-Zinger||Rabin Medical Center|