NCT07262151

Brief Summary

Background: Cancer patients receiving palliative care often endure a variety of distressing symptoms, most notably pain and anxiety. Evidence suggests that music offers a symptom-alleviating effect for these patients and can also influence their physiological parameters. Aim: This investigation was structured as a quasi-experimental study utilizing a pre-test and post-test design with a control group. Its goal was to ascertain the influence of music on pain levels, anxiety states, and vital signs among cancer patients admitted to a palliative care facility. Methods: Data collection relied on the Patient Demographic Form, the Visual Analog Scale (VAS), the State-Trait Anxiety Inventory (STAI), and a Physiological Parameter Monitoring Form. The intervention group was exposed to relaxing instrumental Turkish music in the maqams of Hicaz and Buselik for a single 30-minute session using MP3 players and headphones, whereas the control group was instructed to observe 30 minutes of bed rest without any other activity. Measurements were taken at baseline (pre-intervention) and immediately after the 30-minute intervention period between 10:00 AM and 5:00 PM following the patient's morning analgesic dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

November 16, 2025

Last Update Submit

November 22, 2025

Conditions

Keywords

AnxietyCancerMusicPainPalliative careVital signs

Outcome Measures

Primary Outcomes (1)

  • • Visual Analog Scale

    A standard 10 cm tool (Price et al., 1983) where patients mark their current pain level (0 = no pain, 10 = worst possible pain).

    Baseline (Pre-Intervention) and Immediately Post-Intervention (Total 30-minute intervention period).

Secondary Outcomes (2)

  • State Anxiety (State-Trait Anxiety Inventory - State Subscale)

    Baseline (Pre-Intervention) and Immediately After Intervention (30-minute intervention period).

  • Trait Anxiety (State-Trait Anxiety Inventory - Trait Subscale)

    Baseline (Pre-Intervention) only.

Other Outcomes (6)

  • Systolic Blood Pressure (mmHg)

    Baseline (Pre-Intervention) and Immediately Post-Intervention (30-minute intervention period).

  • Diastolic Blood Pressure (mmHg)

    Baseline (Pre-Intervention) and Immediately Post-Intervention (30-minute intervention period).

  • Heart Rate (beats per minute)

    Baseline (Pre-Intervention) and Immediately Post-Intervention (30-minute intervention period).

  • +3 more other outcomes

Study Arms (2)

Music Intervention Group

EXPERIMENTAL

Before the single-session intervention, the researcher administered the Patient Description Form, STAI, and VAS, and recorded baseline vital signs (Blood Pressure, Pulse Rate, Respiratory Rate, Body Temperature, SpO2). The intervention was scheduled between 10:00 a.m. and 5:00 p.m. following the patient's morning analgesic dose. Participants rested comfortably for 30 minutes while listening to music using an MP3 player and headphones. Headphones were used to enhance focus and minimize external noise, with separate devices used for each patient to adhere to infection control standards. Immediately post-intervention (second follow-up), VAS, State Anxiety Inventory, and vital signs were re-measured and recorded.

Other: Music Application

Control Group

OTHER

Procedures for the Control Group

Other: Procedures for the Control Group

Interventions

Before the single-session intervention, the researcher administered the Patient Description Form, STAI, and VAS, and recorded baseline vital signs (Blood Pressure, Pulse Rate, Respiratory Rate, Body Temperature, SpO2). The intervention was scheduled between 10:00 a.m. and 5:00 p.m. following the patient's morning analgesic dose. Participants rested comfortably for 30 minutes while listening to music using an MP3 player and headphones. Headphones were used to enhance focus and minimize external noise, with separate devices used for each patient to adhere to infection control standards. Immediately post-intervention (second follow-up), VAS, State Anxiety Inventory, and vital signs were re-measured and recorded.

Music Intervention Group

The control group followed the same two-phase data collection protocol as the intervention group (first follow-up). After baseline data collection, the control group was instructed to rest quietly in bed for 30 minutes without any other activity. Immediately after the rest period (second follow-up), the VAS, State Anxiety Inventory, and vital signs were measured and recorded.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with cancer
  • Receiving palliative care treatment at Yozgat City Hospital or Karaman Training and Research Hospital
  • Hospitalized in the palliative care center for at least 7 days
  • Aged 18 years or older
  • Able to speak and understand Turkish
  • Able to communicate verbally
  • Oriented to place and time
  • No psychiatric disease
  • No vision or hearing problems
  • Self-reported pain intensity of at least 3 on the Visual Analog Scale in the last 24 hours
  • Voluntarily agreed to participate in the study
  • Provided written informed consent

You may not qualify if:

  • Underwent major surgical intervention within the last month
  • Currently using another complementary and integrative treatment (e.g., aromatherapy, acupuncture)
  • Cognitive impairment preventing questionnaire completion
  • Not open to communication
  • Died within seven days of hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat city hospital

Yozgat, Merkez, 66000, Turkey (Türkiye)

Location

Related Publications (1)

  • de Witte M, Pinho ADS, Stams GJ, Moonen X, Bos AER, van Hooren S. Music therapy for stress reduction: a systematic review and meta-analysis. Health Psychol Rev. 2022 Mar;16(1):134-159. doi: 10.1080/17437199.2020.1846580. Epub 2020 Nov 27.

    PMID: 33176590BACKGROUND

MeSH Terms

Conditions

NeoplasmsCancer PainAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Pınar Tekinsoy Kartın

    https://sbf.erciyes.edu.tr/

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a quasi-experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 3, 2025

Study Start

February 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations