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

August 21, 2014 updated by: University of Southampton
To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 5YA
        • Complete Fertility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music
Played music during embryo transfer
Other: Music
Self-selected music played via headphones
NO_INTERVENTION: Control
No music played during embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: 20 minutes
Participants completed the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores were compared.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Background anxiety
Time Frame: 20 minutes prior to ET
Background anxiety is the state anxiety of the women
20 minutes prior to ET
Quality of life scores
Time Frame: 20 minutes prior to ET
Quality of life scores as measured by a specific fertility questionnaire
20 minutes prior to ET
Ongoing pregnancy rate
Time Frame: At 2 weeks and 6 weeks after ET
Ongoing pregnancy rate as measured by BHG and ultrasound
At 2 weeks and 6 weeks after ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (ESTIMATE)

August 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RHMO&G0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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