Nurse-Led Staged Art Therapy Effects on Psychological Distress and Pregnancy Outcomes in AIH: RCT

March 18, 2026 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • The Fouth Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group : on the basis of the control group with music therapy.
on the basis of the control group with music therapy.
Other: music therapy
Experimental group : on the basis of the control group with music therapy.
No Intervention: The control group was given routine nursing care
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pregnant was checked 14 days after the end of artificial insemination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-2025-193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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