Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07217418
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. 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.
Study:
NCT07217418
Study Brief:
Protocol Section:
NCT07217418