NCT02223845

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

August 20, 2014

Last Update Submit

August 21, 2014

Conditions

Anxiety

Keywords

Music, Anxiety, IVF

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Background anxiety

    20 minutes prior to ET

  • Quality of life scores

    20 minutes prior to ET

  • Ongoing pregnancy rate

    At 2 weeks and 6 weeks after ET

Study Arms (2)

Music

EXPERIMENTAL

Played music during embryo transfer

Other: Music

Control

NO INTERVENTION

No music played during embryo transfer

Interventions

MusicOTHER

Self-selected music played via headphones

Music

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Women unable to consent or with hearing impairment were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complete Fertility

Southampton, Hampshire, SO16 5YA, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 22, 2014

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

GB(1)