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OpenTrials
Completed

NCT Number: NCT02223845

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

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Complete Fertility

Southampton, Hampshire, SO16 5YA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Other

Self-selected music played via headphones

Primary outcomes

  1. 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.

Secondary outcomes

  1. Background anxiety

    Time frame: 20 minutes prior to ET

    Background anxiety is the state anxiety of the women

  2. Quality of life scores

    Time frame: 20 minutes prior to ET

    Quality of life scores as measured by a specific fertility questionnaire

  3. Ongoing pregnancy rate

    Time frame: At 2 weeks and 6 weeks after ET

    Ongoing pregnancy rate as measured by BHG and ultrasound

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 22, 2014
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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