Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.

NCT ID: NCT02223845

Last Updated: 2014-08-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-01-31

Brief Summary

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To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.

Detailed Description

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An assessor-blinded randomized case control study in an IVF center, England UK will randomise women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores will be compared.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Music

Played music during embryo transfer

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Self-selected music played via headphones

Control

No music played during embryo transfer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Self-selected music played via headphones

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Eligible participants were women aged between 25-40 years, undergoing IVF or ICSI with fresh or frozen embryos to completion from February 2013 to December 2013.

Exclusion Criteria

Women unable to consent or with hearing impairment were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Complete Fertility

Southampton, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RHMO&G0201

Identifier Type: -

Identifier Source: org_study_id

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