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The efficacy and safety of mindfulness music therapy and stress ball relaxation technique in reducing anxiety during acupuncture: a randomized 2x2 factorial open-label trial

The efficacy and safety of mindfulness music therapy and stress ball relaxation technique in reducing anxiety during acupuncture: a randomized 2x2 factorial open-label trial - The efficacy and safety of mindfulness music therapy and stress ball relaxation technique in reducing anxiety during acupuncture

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101341
Enrollment
Unknown
Registered
2025-04-23
Start date
2024-09-02
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid diseases

Interventions

Control Group:Control group: Conventional nursing procedures were adopted. Before the examination, the examinees were questioned about any underlying diseases and anticoagulant use. They were instruct
Stress Ball Group:The stress-relief ball group received stress-relief ball relaxation therapy in addition to routine nursing care
Music Group:The music group received mindfulness - based music therapy in addition to routine nursing care
Combined Group:The combined group received routine nursing care along with stress-relief ball and mindfulness - based music therapies

Sponsors

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a clinical diagnosis requiring thyroid fine-needle aspiration (FNA) or cervical lymph node FNA. 2. Ages between 18 and 80 years old. 3. With normal cognitive communication abilities, capable of accepting and understanding the introduction and guidance of mindfulness music therapy and stress ball relaxation therapy. 4. Capable of understanding and cooperating with the research-related procedures, and signing the informed consent form, consenting to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Individuals with severe communication disorders. 2. Individuals with hearing and comprehension impairments. 3. Patients with coagulation function abnormalities, as well as severe dysfunction of vital organs such as the heart, liver, and kidneys. 4. Patients diagnosed with severe psychological or psychiatric disorders who are unwilling or unable to cooperate with the research procedures. 5. Individuals who have received similar intervention methods, such as music therapy or relaxation therapy. 6. History of allergy to local anesthetics.

Design outcomes

Primary

MeasureTime frame
The change in Hamilton Anxiety Scale score from before to after the examination;

Secondary

MeasureTime frame
Patients' stress responses before and after thyroid fine-needle aspiration;Doctors' satisfaction score;Patient satisfaction score;

Countries

Chian

Contacts

Public ContactLiuchunxia

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

liuchx27@mail.sysu.edu.cn+86 20 3407 1020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026