Effect of Music on Pain and Anxiety in Palliative Cancer Patients

NCT ID: NCT07262151

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Advances in medicine have increased life expectancy, leading to a rise in chronic diseases like cancer, with 14 million new cases annually, projected to reach 22 million by 2030. Cancer patients often face intensive treatments and severe symptoms, including pain and anxiety, highlighting the need for palliative care.

Nurses play a key role in symptom management, using both pharmacological and non-pharmacological methods, including music therapy. Music can stimulate neuroendocrine responses by increasing dopamine and serotonin release, activating the limbic system, increasing endorphin release, and suppressing sympathetic nervous system activity, which contributes significantly to reducing pain and anxiety while also affecting the regulation of vital signs such as blood pressure, pulse, body temperature, respiratory rate, and oxygen saturation.

This study examined the effects of music on pain, anxiety, and vital signs in 32 palliative care cancer patients using a quasi-experimental design with a pretest-posttest control group. The study was conducted between February 2021 and June 2022 at Yozgat City Hospital Palliative Care Center and Karaman Training and Research Hospital Palliative Care Center.

Patients in the intervention group listened to 30 minutes of instrumental Turkish music in the maqams of Hicaz and Buselik; controls rested quietly. The music CD was prepared by experts from the Applied Music Therapy Association (UMTED) and consisted of 13 instrumental works designed to provide relaxation and have a sedative effect. The volume was kept low and the main melody was emphasized.

Data collection took approximately 60 minutes per participant. The intervention was performed between 10:00 AM and 5:00 PM after patients received their first daily analgesic dose. Headphones were used to maintain focus and block extraneous noise, with separate devices for each patient to ensure infection control standards. Further research should explore mechanisms, patient differences, and optimal implementation protocols.

Conditions

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Cancer Cancer Pain Palliative Care Anxiety Music Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

a quasi-experimental design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music Intervention Group

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.

Group Type EXPERIMENTAL

Music Application

Intervention Type OTHER

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.

Control Group

Procedures for the Control Group

Group Type OTHER

Procedures for the Control Group

Intervention Type OTHER

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.

Interventions

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Music Application

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.

Intervention Type OTHER

Procedures for the Control 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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Gülsüm Kehribar

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pınar Tekinsoy Kartın

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Yozgat city hospital

Yozgat, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33176590 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KMU-SHMYO-GK-01

Identifier Type: -

Identifier Source: org_study_id

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