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
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00763126
First received: September 28, 2008
Last updated: September 29, 2008
Last verified: September 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014