Clinical trial NCT06115850: Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy
Official title: Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Anxiety
Music Intervention
Radiation Therapy
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective randomized trial evaluated the effect of music interventions on anxiety and nervousness during 10 consecutive days in individuals undergoing their first radiation therapy session.

Detailed description: A total of 100 participants were enrolled and randomly assigned to either the music group or nonmusic group (n = 50 each). Investigators ensured an equal distribution of men and women, without considering the cancer type. To minimize confounding factors and prevent shared learning experiences or communication between the two groups, the participants in the experimental and control groups were scheduled for treatment at different times throughout the year (from January 1, 2022 to December 31, 2022). Anxiety assessment questionnaires were administered before the treatment began and after 2 weeks of treatment. Physiological parameters, including heart rate, systolic and diastolic blood pressure, and blood oxygen levels, were monitored before and after 2 weeks of treatment. In the music intervention group, the patients received music intervention during RT for 10 consecutive days and listened to music for approximately 10-15 minutes in each session. The music period was then followed by a 10-day period without music during treatment to evaluate the differences in the same individuals. In contrast, the control group did not receive music intervention throughout their entire RT period. Investigators observed the music intervention group for 2 weeks to ascertain any differences.

Eligibility criteria: Inclusion Criteria:

* patients undergoing RT for cancer for the first time
* patients with clear consciousness and normal hearing
* patients willing to respond to the questionnaire after the research process and purpose were explained to them.

Exclusion Criteria:

* patients who had previously undergone RT
* patients with diminished mental capacity or inability to satisfactorily participate in this study
* patients with moderate to severe hearing impairment.

Primary outcomes:
measure: The physiological indicators - Heart rate
timeFrame: monitored before and after 2 weeks of treatment.
measure: The physiological indicators - Blood pressure
timeFrame: monitored before and after 2 weeks of treatment.
measure: The physiological indicators - Blood oxygen
timeFrame: monitored before and after 2 weeks of treatment.
measure: The anxiety status - Distress Thermometer
timeFrame: monitored before and after 2 weeks of treatment.
measure: The anxiety status - Brief Symptom Rating Scale (BSRS-5)
timeFrame: monitored before and after 2 weeks of treatment.
measure: The anxiety status - Beck Anxiety Inventory (BAI-C)
timeFrame: monitored before and after 2 weeks of treatment.
measure: The anxiety status - Symptom Distress Thermometer (SDT)
timeFrame: monitored before and after 2 weeks of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University
state: Taiwan (r.o.c.)
Study officials:
References: