AnxietyNCT02223845
Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.
A study testing Music in people with Anxiety, run by University of Southampton at 1 site in United Kingdom.
Trial summary
To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Women unable to consent or with hearing impairment were excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Complete Fertility
Southampton, Hampshire, SO16 5YA
About this study
To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Music
- Keywords
- Music, Anxiety, IVF
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Self-selected music played via headphones
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Played music during embryo transfer Receives: Other: Music |
| Control | No intervention | No music played during embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Participants completed the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores were compared.
Measured: 20 minutes
Secondary outcomes (3)
Background anxiety
Background anxiety is the state anxiety of the women
Measured: 20 minutes prior to ET
Quality of life scores
Quality of life scores as measured by a specific fertility questionnaire
Measured: 20 minutes prior to ET
Ongoing pregnancy rate
Ongoing pregnancy rate as measured by BHG and ultrasound
Measured: At 2 weeks and 6 weeks after ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223845
- Sponsor's protocol ID
- RHMO&G0201
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.
- ClinicalTrials.gov ID
- NCT02223845
- Acronym / sponsor ID
- RHMO&G0201
- Conditions
- Anxiety
- Keywords
- Music, Anxiety, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicPlayed music during embryo transfer |
| Control | No intervention | –No music played during embryo transfer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women unable to consent or with hearing impairment were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicSelf-selected music played via headphones | Other | Music |
Primary outcome
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.
3 secondary outcomes
Background anxiety
Time frame: 20 minutes prior to ET
Quality of life scores
Time frame: 20 minutes prior to ET
Ongoing pregnancy rate
Time frame: At 2 weeks and 6 weeks after ET
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Anxiety, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.