Music Therapy and Its Effects on Premenstrual Syndrome (PMS)

NCT ID: NCT07217418

Last Updated: 2025-10-16

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-06-01

Brief Summary

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The purpose of the research is to explore the effects of music therapy on premenstrual syndrome and its symptoms. The goal of this study is to answer the following research questions:

1. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the physiological responses (EMG, skin conductance, and heart rate) of college students with PMS?
2. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the brain wave (EEG) of college students with PMS?
3. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the anxiety level of college students with PMS?
4. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the pain perception of college students with PMS?
5. How do college students with PMS respond after listening to music, singing, and instrumental playing?

Participants were randomly assigned to one of three groups: a passive music-listening group, an active singing group, or an active instrumental-playing group. Physiological responses were collected before, during, and after the intervention. Participants who volunteered completed a written survey following the intervention.

Detailed Description

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Upon IRB approval for this research, an email invitation was distributed to a private university in Northeastern Pennsylvania. The Premenstrual Syndrome Scale (PMSS) was used to screen participants to measure the severity of PMS symptoms. PMSS consists of 44 items and has nine sub-dimensions: depressive sensation, anxiety, fatigue, nervousness, depressive thoughts, pain, appetite changes, and sleep pattern. Each item is scored, and a high score indicates intense PMS symptoms. Demographic questions were followed to identify participants' background information, including their musical background, age, and general symptoms of PMS. Once participants were recruited, they were randomly assigned into three groups. The participants in the listening group listened to 30 minutes of meditative music, while the playing and singing groups utilized 30 minutes of either the listening or singing of preferred music led by a music therapy student under a certified music therapist's supervision. Each participant scheduled an appointment with a student music therapist within ten days of their menstrual period. This experiment will consist of several pre-, during, and post-tests. First, participants received an electroencephalogram (EEG) test to measure the electrical activities in their brains through the Biofeedback ProComp Infinity System with BioGraph Infiniti Software-T7500M. Electromyography (EMG) was used to measure the electrical activity of the participant's muscle tension using this equipment. In addition, respiratory rate, heart rate, and temperature were measured. Additionally, the participants completed both an anxiety self-report (State-Trait Anxiety Inventory) and a pain perception self-report pre-and post-test. Finally, 10 participant completed a qualitative questionnaire survey only for their post-test.

Conditions

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Premenstrual Syndrome Menstrual Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music Listening Group

Group Type ACTIVE_COMPARATOR

Music Listening Group (LG)

Intervention Type BEHAVIORAL

The Listening Group (LG) listened to a randomly selected song that featured a slow tempo, a major key, and sedative music, and listened to pre-recorded music for 15-20 minutes without an interventionist. All sessions were conducted individually in a quiet, private music therapy room to ensure a controlled, distraction-free environment. Participants were seated comfortably, and a researcher responsible for monitoring their physiological responses remained present but positioned to avoid direct eye contact.

Singing Group

Group Type EXPERIMENTAL

Participant-Selected Songs for the Interactive Singing Intervention Group (SG)

Intervention Type BEHAVIORAL

The researchers curated a list of 23 songs based on participants' preferred genres and artists, as identified through an initial survey. These songs, characterized by an upbeat tempo (80-110 BPM) and major key tonality, were selected to reflect common musical elements aligned with participants' preferences. All sessions were conducted individually in a quiet, private music therapy room to ensure a controlled, distraction-free environment. Participants were seated comfortably facing the interventionist, while a researcher responsible for monitoring physiological responses remained present but positioned to avoid direct eye contact. Participants in the Singing Group (SG) selected a song from the curated list, received a lyric sheet, and sang along as the interventionist provided vocal and guitar accompaniment.

Instrumental Playing Group

Group Type EXPERIMENTAL

Participant-Selected Songs for the Interactive Instrumental Playing Group (PG)

Intervention Type BEHAVIORAL

The researchers selected 23 songs based on participants' preferred genres and artists, as identified through an initial survey. These songs, characterized by an upbeat tempo (80-110 BPM) and major key tonality, were chosen to reflect musical elements commonly found in participants' preferences. All sessions were conducted individually in a quiet, private music therapy room to ensure a controlled, distraction-free environment. Each participant was seated in a comfortable chair facing the interventionist, while a researcher monitoring physiological responses remained present but positioned to avoid direct eye contact. Participants in the Playing Group (PG) selected a preferred song from the curated list and played a full-sized djembe while listening to live music performed by the interventionist, who provided vocal and guitar accompaniment. To maintain rhythmic focus, participants were instructed not to sing while playing the drum.

Interventions

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Music Listening Group (LG)

The Listening Group (LG) listened to a randomly selected song that featured a slow tempo, a major key, and sedative music, and listened to pre-recorded music for 15-20 minutes without an interventionist. All sessions were conducted individually in a quiet, private music therapy room to ensure a controlled, distraction-free environment. Participants were seated comfortably, and a researcher responsible for monitoring their physiological responses remained present but positioned to avoid direct eye contact.

Intervention Type BEHAVIORAL

Participant-Selected Songs for the Interactive Singing Intervention Group (SG)

The researchers curated a list of 23 songs based on participants' preferred genres and artists, as identified through an initial survey. These songs, characterized by an upbeat tempo (80-110 BPM) and major key tonality, were selected to reflect common musical elements aligned with participants' preferences. All sessions were conducted individually in a quiet, private music therapy room to ensure a controlled, distraction-free environment. Participants were seated comfortably facing the interventionist, while a researcher responsible for monitoring physiological responses remained present but positioned to avoid direct eye contact. Participants in the Singing Group (SG) selected a song from the curated list, received a lyric sheet, and sang along as the interventionist provided vocal and guitar accompaniment.

Intervention Type BEHAVIORAL

Participant-Selected Songs for the Interactive Instrumental Playing Group (PG)

The researchers selected 23 songs based on participants' preferred genres and artists, as identified through an initial survey. These songs, characterized by an upbeat tempo (80-110 BPM) and major key tonality, were chosen to reflect musical elements commonly found in participants' preferences. All sessions were conducted individually in a quiet, private music therapy room to ensure a controlled, distraction-free environment. Each participant was seated in a comfortable chair facing the interventionist, while a researcher monitoring physiological responses remained present but positioned to avoid direct eye contact. Participants in the Playing Group (PG) selected a preferred song from the curated list and played a full-sized djembe while listening to live music performed by the interventionist, who provided vocal and guitar accompaniment. To maintain rhythmic focus, participants were instructed not to sing while playing the drum.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants were biologically female individuals who reported experiencing premenstrual syndrome (PMS) in the initial survey and were currently in their menstrual cycle. Only those who were 7-10 days prior to the onset of their period were eligible to participate in the intervention.

Exclusion Criteria

* Individuals who identify as transgender women
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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West Chester University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eun Sil Suh, PhD

Role: PRINCIPAL_INVESTIGATOR

West Chester University

Locations

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Marywood University

Scranton, Pennsylvania, United States

Site Status

Countries

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United States

References

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Saglam HY, Basar F. The relationship between premenstrual syndrome and anger. Pak J Med Sci. 2019 Mar-Apr;35(2):515-520. doi: 10.12669/pjms.35.2.232.

Reference Type BACKGROUND
PMID: 31086543 (View on PubMed)

Arjmand HA, Hohagen J, Paton B, Rickard NS. Emotional Responses to Music: Shifts in Frontal Brain Asymmetry Mark Periods of Musical Change. Front Psychol. 2017 Dec 4;8:2044. doi: 10.3389/fpsyg.2017.02044. eCollection 2017.

Reference Type BACKGROUND
PMID: 29255434 (View on PubMed)

Other Identifiers

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PMSMT2025

Identifier Type: -

Identifier Source: org_study_id

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