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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00763126
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Behavioral: stress level	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• 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: Oct 1, 2008
• Anticipated Primary Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spouse present,	Behavioral: stress level; Stress levels
Active Comparator: spouse absent	Behavioral: stress level; Stress levels

Outcome Measures

Primary Outcome Measures

1. Stress levels [1 year]

Secondary Outcome Measures

1. hemodynamic parameters [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Healthy term parturients

Exclusion Criteria:

• Diabetes

• Preterm labor

• Mouth pathologies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tikvah		Israel

Sponsors and Collaborators

• Rabin Medical Center

Investigators

• Principal Investigator: Sharon Orbach-Zinger, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00763126
• Other Study ID Numbers: 5053
• First Posted: Sep 30, 2008
• Last Update Posted: Sep 30, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: parturient; epidural analgesia; labor; spouse; Stress levels; Salivary amylase
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Sep 30, 2008