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

Clalit Health Services

Status: Unknown

Conditions: Labor Pain

Treatments: Behavioral: stress level

Study type: Interventional

Funder types: Other

Identifiers

NCT00763126

5053

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy term parturients

Exclusion criteria

• Diabetes
• Preterm labor
• Mouth pathologies

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Spouse present,

Active Comparator group

Treatment:

Behavioral: stress level

spouse absent

Active Comparator group

Treatment:

Behavioral: stress level