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

September 29, 2008 updated by: Rabin Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petach Tikvah, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy term parturients

Exclusion Criteria:

  • Diabetes
  • Preterm labor
  • Mouth pathologies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stress levels
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
hemodynamic parameters
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

September 28, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

September 30, 2008

Last Update Submitted That Met QC Criteria

September 29, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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