Music Therapy and Its Effects on Premenstrual Syndrome (PMS)

NCT07217418 | Completed

• 1 other identifier: PMSMT2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 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. 5.How do college students with PMS respond after listening to music, singing, and instrumental playing?

Conditions

Premenstrual Syndrome; Menstrual Symptoms

Keywords

Music therapy; PMS; Premenstrual syndrome; Music Based Intervention

Outcome Measures

Primary Outcomes (6)

• Alpha Wave Activity (EEG)

  Alpha wave activity was measured using electroencephalography (EEG) via the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M). Alpha amplitude was reported in microvolts (µV) to assess relaxation-related brain activity.

  It was a one-time intervention on the same day (day 1), each participant with assessments immediately before the intervention (baseline), during the intervention, and immediately after the intervention (post-test).

• Muscle Tension (EMG)

  Muscle tension was assessed using electromyography (EMG) recorded with the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M). EMG amplitude was reported in microvolts (µV).

  It was a one-time intervention on the same day (day 1), each participant with assessments immediately before the intervention (baseline), during the intervention, and immediately after the intervention (post-test).

• Heart Rate

  Heart rate was recorded using the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M) and reported in beats per minute (bpm).

  It was a one-time intervention on the same day (day 1), each participant with assessments immediately before the intervention (baseline), during the intervention, and immediately after the intervention (post-test)

• Skin Conductance (SC)

  Skin conductance(SC) was recorded using the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M) to evaluate autonomic arousal. Data was expressed in microsiemens (µS).

  It was a one-time intervention on the same day (day 1), each participant with assessments immediately before the intervention (baseline), during the intervention, and immediately after the intervention (post-test).

• Anxiety (State-Trait Anxiety Inventory; STAI)

  Anxiety levels were assessed using the State-Trait Anxiety Inventory. Scores were reported as units on a scale from 20 to 80, with higher scores indicating greater anxiety.

  This was a one-time intervention conducted on Day 1. Each participant completed assessments at baseline (pre-intervention, prior to physiological measurements) and immediately post-intervention (following completion of physiological measurements).

• Pain Perception

  Pain perception was measured using a self-report questionnaire. Scores were reported on a numeric rating scale from 0 to 10, with higher scores indicating greater perceived pain intensity.

  This was a one-time intervention conducted on Day 1. Each participant completed assessments at baseline (pre-intervention, prior to physiological measurements) and immediately post-intervention (following completion of physiological measurements).

Secondary Outcomes (1)

• Qualitative questionnaire survey

  Assessments were conducted immediately post-intervention (following completion of physiological, anxiety, and pain measurements). It was a one-time intervention conducted on Day 1.

Study Arms (3)

Music Listening Group

ACTIVE COMPARATOR

Behavioral: Music Listening Group (LG)

Singing Group

EXPERIMENTAL

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

Instrumental Playing Group

EXPERIMENTAL

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

Interventions

Music Listening Group (LG) 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.

Music Listening Group

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

Singing Group

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

Instrumental Playing Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals who identify as transgender women

Sponsors & Collaborators

• West Chester University of Pennsylvania: lead

Study Sites (1)

Marywood University

Scranton, Pennsylvania, 18509, United States

Location

Related Publications (2)

• 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.

  PMID: 31086543 BACKGROUND

• 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.

  PMID: 29255434 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eun Sil Suh, PhD

  West Chester University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 16, 2025
• Study Start: February 1, 2024
• Primary Completion: May 20, 2024
• Study Completion: June 1, 2024
• Last Updated: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)