Premenstrual SyndromePMSNCT07217418
Music Therapy and Its Effects on Premenstrual Syndrome (PMS)
A study testing Music Listening Group (LG), Participant-Selected Songs for the Interactive Singing Intervention Group (SG) and Participant-Selected Songs for the Interactive Instrumental Playing Group (PG) in people with Premenstrual Syndrome and Menstrual Symptoms, run by West Chester University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premenstrual Syndrome, Menstrual Symptoms
- What is being tested?
- Music Listening Group (LG), Participant-Selected Songs for the Interactive Singing Intervention Group (SG) and Participant-Selected Songs for the Interactive Instrumental Playing Group (PG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who identify as transgender women
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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?
- 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?
- 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?
- 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?
- 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.
Read the 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
- Premenstrual Syndrome, Menstrual Symptoms
- Being tested
- Music Listening Group (LG), Participant-Selected Songs for the Interactive Singing Intervention Group (SG), Participant-Selected Songs for the Interactive Instrumental Playing Group (PG)
- Keywords
- Music therapy, PMS, Premenstrual syndrome, Music Based Intervention
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening Group (LG)Behavioural
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.
Participant-Selected Songs for the Interactive Singing Intervention Group (SG)Behavioural
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.
Participant-Selected Songs for the Interactive Instrumental Playing Group (PG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Listening Group | Active comparator | Not described Receives: Behavioral: Music Listening Group (LG) |
| Singing Group | Experimental | Not described Receives: Behavioral: Participant-Selected Songs for the Interactive Singing Intervention Group (SG) |
| Instrumental Playing Group | Experimental | Not described Receives: Behavioral: Participant-Selected Songs for the Interactive Instrumental Playing Group (PG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
A qualitative questionnaire was developed by the investigators and administered only during the post-test. The questionnaire included open-ended questions such as, 'What was your most memorable experience during this live music session?' and 'How did you feel before and after participating in the music-based intervention?
Measured: Assessments were conducted immediately post-intervention (following completion of physiological, anxiety, and pain measurements). It was a one-time intervention conducted on Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start1 Feb 2024
- Primary completion20 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Chester University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun Sil Suh, PhD, Principal investigator, West Chester University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217418
- Sponsor's protocol ID
- PMSMT2025
- Acronym
- PMS
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31086543Arjmand 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.
PubMed 29255434
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy and Its Effects on Premenstrual Syndrome (PMS)
- ClinicalTrials.gov ID
- NCT07217418
- Acronym / sponsor ID
- PMS / PMSMT2025
- Conditions
- Premenstrual Syndrome, Menstrual Symptoms
- Keywords
- Music therapy, PMS, Premenstrual syndrome, Music Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- West Chester University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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?
- 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?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals who identify as transgender women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Music Listening Group |
| 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. | Behavioural | Singing Group |
| 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. | Behavioural | Instrumental Playing Group |
Primary outcome
Alpha Wave Activity (EEG)
Time frame: 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).
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.
Muscle Tension (EMG)
Time frame: 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 was assessed using electromyography (EMG) recorded with the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M). EMG amplitude was reported in microvolts (µV).
Heart Rate
Time frame: 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 was recorded using the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M) and reported in beats per minute (bpm).
Skin Conductance (SC)
Time frame: 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) was recorded using the Biofeedback ProComp Infinity System BioGraph Infiniti Software (T7500M) to evaluate autonomic arousal. Data was expressed in microsiemens (µS).
Anxiety (State-Trait Anxiety Inventory; STAI)
Time frame: 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).
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.
Pain Perception
Time frame: 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 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.
1 secondary outcome
Qualitative questionnaire survey
Time frame: Assessments were conducted immediately post-intervention (following completion of physiological, anxiety, and pain measurements). It was a one-time intervention conducted on Day 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Background: PubMed 31086543Saglam 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.
- Background: PubMed 29255434Arjmand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Sil Suh, PhD principal investigator
West Chester University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening Group (LG), Participant-Selected Songs for the Interactive Singing Intervention Group (SG) and Participant-Selected Songs for the Interactive Instrumental Playing Group (PG) in people with Premenstrual Syndrome and Menstrual Symptoms, run by West Chester University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha Wave Activity (EEG) (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07217418, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.