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

NCT ID: NCT00763126

Last Updated: 2008-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Pain

Keywords

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parturient epidural analgesia labor spouse Stress levels Salivary amylase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Spouse present,

Group Type ACTIVE_COMPARATOR

stress level

Intervention Type BEHAVIORAL

Stress levels

spouse absent

Group Type ACTIVE_COMPARATOR

stress level

Intervention Type BEHAVIORAL

Stress levels

Interventions

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stress level

Stress levels

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy term parturients

Exclusion Criteria

* Diabetes
* Preterm labor
* Mouth pathologies
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anesthesiology department

Principal Investigators

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Sharon Orbach-Zinger

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Rabin Medical Center

Petach Tikvah, , Israel

Site Status

Countries

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Israel

Central Contacts

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Sharon Orbach-Zinger, M.D

Role: CONTACT

Phone: 039376811

Email: [email protected]

Other Identifiers

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5053

Identifier Type: -

Identifier Source: org_study_id