Trials / Completed
CompletedNCT07217418
Music Therapy and Its Effects on Premenstrual Syndrome (PMS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- West Chester University of Pennsylvania · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| 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. |
| 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. |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2024-05-20
- Completion
- 2024-06-01
- First posted
- 2025-10-16
- Last updated
- 2025-10-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07217418. Inclusion in this directory is not an endorsement.