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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
Sponsor:
Information provided by:

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
Labor Pain Behavioral: stress level

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2008
Estimated Primary Completion Date : October 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 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. hemodynamic parameters [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy term parturients

Exclusion Criteria:

  • Diabetes
  • Preterm labor
  • Mouth pathologies
Contacts and Locations

Information from the National Library of Medicine

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


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

Responsible Party: Sharon Orbach-Zinger, M.D, Anesthesiology department
ClinicalTrials.gov Identifier: NCT00763126     History of Changes
Other Study ID Numbers: 5053
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008

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