Music TherapyNCT07356830
Nurse-Led Staged Art Therapy Effects on Psychological Distress and Pregnancy Outcomes in AIH: RCT
A study testing music therapy in people with Music Therapy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Music therapy is a comprehensive therapy that integrates musicology, psychology and medicine. It is an application and development outside the field of traditional art appreciation and aesthetics . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music Therapy
- What is being tested?
- music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Inclusion Criteria:①aged 20-40 years old, conscious, with normal language expression ability and understanding ability ;②Exclusion of mental illness and serious diseases of vital organs, voluntary participation in the survey. ③ Patients who met the WHO diagnostic criteria for infertility : those who had normal sexual life after marriage without contraception for 1 year or more.
Exclusion Criteria:①Those who could not cooperate with the scale due to deafness, dumbness, aphasia and disturbance of consciousness ; ② patients with mental disorders and severe important organ diseases.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fouth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
About this study
Official title: Effect of Music Therapy on Psychological State and Pregnancy Outcome of Patients With Artificial Insemination
Music therapy is a comprehensive therapy that integrates musicology, psychology and medicine. It is an application and development outside the field of traditional art appreciation and aesthetics . Clinical studies have shown that music therapy can improve the patient 's sense of tension, relieve anxiety, and has a certain effect of auxiliary analgesia. At the same time, music therapy is easy to operate, economical and feasible, non-invasive and safe , and improves physical and mental health. Music therapy can work through the hypothalamus-pituitary and other multi-system cross-activity, arouse the patient 's pleasant thoughts and emotional experience, and has the function of regulating psychology and physiology . Many studies at home and abroad have shown that most infertility patients have negative emotions, such as anxiety and depression For Chinese women, affected by the traditional culture of " no filial piety, no filial piety, no filial piety, " patients are under greater reproductive pressure. Many studies have confirmed that psychological stress can affect the function of the hypothalamus-pituitary-ovarian axis, inhibit the secretion of gonadotropins by the pituitary gland, interfere with follicular growth, affect the developmental potential of oocytes and embryos, and thus affect reproductive function . Psychological stress can also interfere with embryo implantation by inhibiting endometrial receptivity . Anxiety can promote sympathetic nerve excitation, release more catecholamines, hinder the growth of follicles in the ovary and the secretion of luteinizing hormone, and affect the clinical effect of superovulation. The decrease of estrogen and progesterone secretion affects the number and quality of follicles and the development of endometrium, thus reducing the pregnancy rate Long-term depression can also endanger physical health, destroy pregnancy outcomes, and lead to abortion. With the development of medicine, the ' biological-psychological-social ' medical model has been paid more and more attention, and the psychological factors in the treatment of infertility have also attracted more and more attention. Although the mechanism of music therapy is not yet clear, studies have shown that it can inhibit the secretion of endogenous hormones such as adrenaline.
- Conditions
- Music Therapy
- Being tested
- music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
Experimental group : on the basis of the control group with music therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group : on the basis of the control group with music therapy. | Experimental | on the basis of the control group with music therapy. Receives: Other: music therapy |
| The control group was given routine nursing care | No intervention | In the control group, psychological nursing was supplemented in the process of routine diagnosis and treatment. The main contents are as follows : At the beginning of the filing date of husband 's artificial insemination, nurses carefully understood the basic situation of patients, including the living environment and educational background, and gave patients psychological counseling and care. At the same time, they carried out propaganda and education for patients, explained the treatment process and principle of artificial insemination, dispelled the fear caused by patients ' lack of understanding of treatment technology, eliminated patients ' anxiety, depression and other negative emotions, let patients unload their psychological burden as soon as possible, familiarize themselves with the diagnosis and treatment environment, and improve patients ' self-confidence by introducing successful cases. Promote their active treatment until the end of the entire husband 's artificial insemi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnant was checked 14 days after the end of artificial insemination.
Measured: Pregnant was checked 14 days after the end of artificial insemination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start6 Aug 2025
- Primary completion31 Dec 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356830
- Sponsor's protocol ID
- KY-2025-193
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy on Psychological State and Pregnancy Outcome of Patients With Artificial Insemination
- ClinicalTrials.gov ID
- NCT07356830
- Acronym / sponsor ID
- KY-2025-193
- Conditions
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- 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.
Music therapy is a comprehensive therapy that integrates musicology, psychology and medicine. It is an application and development outside the field of traditional art appreciation and aesthetics . Clinical studies have shown that music therapy can improve the patient 's sense of tension, relieve anxiety, and has a certain effect of auxiliary analgesia. At the same time, music therapy is easy to operate, economical and feasible, non-invasive and safe , and improves physical and mental health. Music therapy can work through the hypothalamus-pituitary and other multi-system cross-activity, arouse the patient 's pleasant thoughts and emotional experience, and has the function of regulating psychology and physiology . Many studies at home and abroad have shown that most infertility patients have negative emotions, such as anxiety and depression For Chinese women, affected by the traditional culture of " no filial piety, no filial piety, no filial piety, " patients are under greater reproductive pressure. Many studies have confirmed that psychological stress can affect the function of the hypothalamus-pituitary-ovarian axis, inhibit the secretion of gonadotropins by the pituitary gland, interfere with follicular growth, affect the developmental potential of oocytes and embryos, and thus affect reproductive function . Psychological stress can also interfere with embryo implantation by inhibiting endometrial receptivity . Anxiety can promote sympathetic nerve excitation, release more catecholamines, hinder the growth of follicles in the ovary and the secretion of luteinizing hormone, and affect the clinical effect of superovulation. The decrease of estrogen and progesterone secretion affects the number and quality of follicles and the development of endometrium, thus reducing the pregnancy rate Long-term depression can also endanger physical health, destroy pregnancy outcomes, and lead to abortion. With the development of medicine, the ' biological-psychological-social ' medical model has been paid more and more attention, and the psychological factors in the treatment of infertility have also attracted more and more attention. Although the mechanism of music therapy is not yet clear, studies have shown that it can inhibit the secretion of endogenous hormones such as adrenaline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group : on the basis of the control group with music therapy. | Experimental | Other: music therapyon the basis of the control group with music therapy. |
| The control group was given routine nursing care | No intervention | –In the control group, psychological nursing was supplemented in the process of routine diagnosis and treatment. The main contents are as follows : At the beginning of the filing date of husband 's artificial insemination, nurses carefully understood the basic situation of patients, including the living environment and educational background, and gave patients psychological counseling and care. At the same time, they carried out propaganda and education for patients, explained the treatment process and principle of artificial insemination, dispelled the fear caused by patients ' lack of understanding of treatment technology, eliminated patients ' anxiety, depression and other negative emotions, let patients unload their psychological burden as soon as possible, familiarize themselves with the diagnosis and treatment environment, and improve patients ' self-confidence by introducing successful cases. Promote their active treatment until the end of the entire husband 's artificial insemi |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| music therapyExperimental group : on the basis of the control group with music therapy. | Other | Experimental group : on the basis of the control group with music therapy. |
Primary outcome
Pregnancy rate
Time frame: Pregnant was checked 14 days after the end of artificial insemination.
Pregnant was checked 14 days after the end of artificial insemination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
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 therapy in people with Music Therapy, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pregnancy rate (time frame: Pregnant was checked 14 days after the end of artificial insemination.). 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 20 Mar 2026.