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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223845
• Other study ID #: RHMO&G0201
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: August 21, 2014
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety

Intervention

Other:
• Music
Self-selected music played via headphones

Locations

Country	Name	City	State
United Kingdom	Complete Fertility	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level	Participants completed the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores were compared.	20 minutes	No
Secondary	Background anxiety	Background anxiety is the state anxiety of the women	20 minutes prior to ET	No
Secondary	Quality of life scores	Quality of life scores as measured by a specific fertility questionnaire	20 minutes prior to ET	No
Secondary	Ongoing pregnancy rate	Ongoing pregnancy rate as measured by BHG and ultrasound	At 2 weeks and 6 weeks after ET	No