Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedSeptember 30, 2008
September 1, 2008
1 year
September 28, 2008
September 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stress levels
1 year
Secondary Outcomes (1)
hemodynamic parameters
1 year
Study Arms (2)
Spouse present,
ACTIVE COMPARATORspouse absent
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy term parturients
You may not qualify if:
- Diabetes
- Preterm labor
- Mouth pathologies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center
Petach Tikvah, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Orbach-Zinger
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 28, 2008
First Posted
September 30, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Last Updated
September 30, 2008
Record last verified: 2008-09