Back to resultsDoes Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
Primary Purpose
Labor Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
stress level
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring parturient, epidural analgesia, labor, spouse, Stress levels, Salivary amylase
Eligibility Criteria
Inclusion Criteria:
- Healthy term parturients
Exclusion Criteria:
- Diabetes
- Preterm labor
- Mouth pathologies
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Spouse present,
spouse absent
Arm Description
Outcomes
Primary Outcome Measures
Stress levels
Secondary Outcome Measures
hemodynamic parameters
Full Information
NCT ID
NCT00763126
First Posted
September 28, 2008
Last Updated
September 29, 2008
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00763126
Brief Title
Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
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 Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
parturient, epidural analgesia, labor, spouse, Stress levels, Salivary amylase
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spouse present,
Arm Type
Active Comparator
Arm Title
spouse absent
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
stress level
Intervention Description
Stress levels
Primary Outcome Measure Information:
Title
Stress levels
Time Frame
1 year
Secondary Outcome Measure Information:
Title
hemodynamic parameters
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy term parturients
Exclusion Criteria:
Diabetes
Preterm labor
Mouth pathologies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Orbach-Zinger, M.D
Phone
039376811
Email
sharonorbach@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Orbach-Zinger
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikvah
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
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