Reproductive HealthNCT06215183
The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application
A study testing Music therapy in people with Reproductive Health and Pain, run by Sümeyye Köse at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health, Pain, Women Health
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Feb 2024
- Phase
- Interventional
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Knowing how to read and write,
- Not having had an IUD inserted before,
- Being between the ages of 18-49,
- No hearing-related problems,
- Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
- Voluntarily participating in the study,
Who cannot join
- The woman has a cognitive and auditory problem
- Having a history of cervical surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pendik District Health Directorate Maternal Child Health and Family Planning Center
Istanbul, Pendik, 34890
About this study
This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction.
Read the detailed description
The randomized controlled and experimental study will be conducted with 70 women who apply to a Maternal and Child Health and Family Planning Center to have an Intrauterine Device (IUD). Women in the experimental group (n=35) will listen to music before, during and after the IUD application process, and the control group (n=35) will undergo routine IUD application. Information Form containing sociodemographic information, Situational Anxiety
- Conditions
- Reproductive Health, Pain, Women Health
- Being tested
- Music therapy
- Keywords
- Intrauterine device, Pain, Anxiety, Satisfaction
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Women applying for IUD application will receive music therapy for 5 minutes before the procedure, during the IUD application, and for 5 minutes after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Women in the intervention group applying for IUD application will listen to music for 5 minutes before, during and after the procedure. Receives: Other: Music therapy |
| Control Group | No intervention | Women in the control group applying for IUD application will not be subjected to any intervention other than routine IUD insertion procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Data will be collected using the State Anxiety Inventory. The answer options collected in four classes on the State Anxiety Inventory scale are: (1) Not at all, (2) A little, (3) A lot and (4) Completely; The options on the trait anxiety scale are (1) Rarel, (2) Sometimes, (3) A lot of the time, and (4) Almost always. The higher the score obtained from the scales, the higher the person's anxiety is. The total score obtained from the scale varies between 20-80, and 20-39 indicates a mild anxiety level, 40-59 indicates a medium anxiety level, 60-79 indicates a high anxiety level, and 80 points indicates a panic anxiety level.
Measured: 30 minütes
Pain Level
Data will be collected using the Visual Analogue Scale. Pain can be given a score between 0 and 10 on the scale.The higher the scale score, the greater the pain.
Measured: 30 minütes
Secondary outcomes (1)
Satisfaction Level
Data will be collected using the Visual Analog Scale. Satisfaction can be given a score between 0 and 10 on the scale. The higher the scale score, the higher the satisfaction level.
Measured: 30 minütes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jun 2023
- Primary completion30 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümeyye Köse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyye Köse, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215183
- Sponsor's protocol ID
- SKOSE
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kose S, Ozcan H, Meseduzu M. Effect of Music on Pain, Anxiety, and Satisfaction During Intrauterine Device Application: A Randomized Clinical Trial. Res Nurs Health. 2026 Jul 16. doi: 10.1002/nur.70105. Online ahead of print.
PubMed 42460703