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NCT00763126 Clinical Trial

Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00763126
Other study ID # 5053
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 28, 2008
Last updated September 29, 2008
Start date October 2008

Study information
Verified date September 2008
Source Rabin Medical Center
Contact Sharon Orbach-Zinger, M.D
Phone 039376811
Email sharonorbach@yahoo.com
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Healthy term parturients

Exclusion Criteria:

- Diabetes

- Preterm labor

- Mouth pathologies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• stress level
Stress levels

Locations
Country Name City State
Israel Rabin Medical Center Petach Tikvah

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stress levels 1 year No
Secondary hemodynamic parameters 1 year No
See also
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