- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07202650
- Original Trial
THE EFFECT OF GUİDED IMAGERY ON PREMENSTRUAL SYNDROME
EFFECT OF GUİDED IMAGERY ON PREMENSİVE SYNDROME İN UNİVERSİTY STUDENTS
EFFECT OF GUIDED IMAGERY ON PREMENSTRUAL SYNDROME IN UNIVERSITY STUDENTS
Premenstrual Syndrome (PMS) is a condition characterized by physical, behavioral, and emotional symptoms that appear at the end of the luteal phase, 7-10 days before menstruation, and resolve with the onset of menstruation. Symptoms include irritability, loss of control, anxiety, depression, sleep disturbances, decreased concentration, unexplained crying, fatigue, weakness, changes in appetite, edema, headaches, joint and muscle pain, breast tenderness, altered sexual activity, and social withdrawal. In young women, PMS can negatively affect self-confidence, social relationships, quality of life, and academic performance.
PMS treatment aims to relieve both physical and psychological symptoms and may include dietary supplements and complementary-alternative therapies. Approaches such as reflexology, pilates, acupressure, music, exercise, and guided imagery have shown promising results in reducing premenstrual symptoms. Mind-body-based approaches in complementary therapies are known to support psychological well-being. Guided imagery, a form of mind-body communication, involves the flow of thoughts and the way the mind encodes, stores, and expresses sensory information. It is based on the understanding that the mind and body are interconnected and that mental processes can influence physical responses. Guided imagery has been shown to reduce stress, improve mood, enhance sleep quality, strengthen the immune system, reduce fatigue, and minimize nausea and vomiting.
Although effective, research on the use of guided imagery to reduce PMS symptoms in university students is limited. This study aims to investigate the effect of guided imagery on premenstrual syndrome in this population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Premenstrual Syndrome (PMS) is a condition characterized by physical, behavioral, and emotional symptoms that typically occur at the end of the luteal phase of a woman's menstrual cycle, 7-10 days before menstruation, and resolve at the onset of menstruation or shortly afterward. When diagnosing PMS, women are advised to keep a symptom diary for at least two menstrual cycles. The diary should document symptoms during the luteal phase and the symptom-free period until ovulation. Underlying physical or psychological conditions that could exacerbate symptoms should also be considered.
PMS can be diagnosed when symptoms occur for at least three consecutive menstrual cycles, beginning within five days before menstruation, ending within four days after menstruation starts, and interfering with normal daily activities. Evaluations should also consider medical, psychological, sociocultural, and lifestyle factors.
Symptoms of PMS include irritability, feelings of loss of control, anxiety, depression, insomnia or hypersomnia, difficulty concentrating, crying for no reason, fatigue, increased appetite, edema, weight gain, dizziness, headaches, joint and muscle pain, breast tenderness, changes in sexual activity, and avoidance of social interactions, among over 200 psychological, physical, and behavioral symptoms. Up to 90% of women of reproductive age report experiencing one or more of these symptoms in the days before menstruation, which can affect behavior, well-being, and social or work environments.
Although the exact cause of PMS is not fully understood, it is believed that endocrine factors-such as carbohydrate intolerance, fluid retention, progesterone deficiency, estrogen imbalance, endorphin deficiency, adrenal or thyroid dysfunction, hyperprolactinemia, and hypoglycemia-along with psychological factors like genetics and stress, contribute to its development.
Traditionally considered a concern for women of reproductive age, PMS is increasingly recognized as a common mental health issue, significantly impairing daily functioning. The COVID-19 pandemic has also been associated with an increase in some PMS symptoms. The wide range of PMS symptoms makes it challenging to determine its true prevalence, which varies widely across studies. Women often use both pharmacological and non-pharmacological strategies to manage physical and psychological symptoms during the premenstrual period. PMS can negatively affect self-confidence, social relationships, quality of life, and academic performance, making effective treatment increasingly important.
Treatment focuses on alleviating both physical and psychiatric symptoms, and may include dietary supplements and complementary-alternative therapies. Complementary approaches such as reflexology, pilates, acupressure, music, exercise, and guided imagery have shown promising results in reducing premenstrual symptoms. Mind-body approaches in complementary therapies are known to have psychological benefits. Among these, relaxation techniques are the most commonly used, aiming to neutralize stress-related physical changes, including muscle tension, high blood pressure, and hormonal fluctuations, while calming the mind.
Guided imagery is a mind-body communication technique that involves the flow of thoughts and how the brain encodes, stores, and recalls sensory information. It is based on the connection between mind and body, recognizing that the mind can influence physiological responses. Stress and anxiety directly affect the brain and immune system. Guided imagery can be practiced with an instructor or through pre-recorded audio or video, and individuals can also practice self-directed imagery, creating their own scenarios. It can be applied in groups or individually. This technique has been shown to reduce stress, improve mood, strengthen the immune system, reduce fatigue, enhance sleep quality, and minimize nausea and vomiting.
Studies among university students have shown that guided imagery effectively alleviates premenstrual symptoms. Additionally, hypnotherapy and virtual reality-based relaxation interventions have been found to reduce PMS symptoms. However, research on using guided imagery specifically for reducing premenstrual symptoms in university students is still limited.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cansu Akdag Topal, Assisstant professor
- Phone Number: +905545386987
- Email: cansua05@gmail.com
Study Locations
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Ankara, Turkey (Türkiye), 06790
- Recruiting
- Baskent University
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Contact:
- Cansu Akdag Topal
- Phone Number: 05545386987
- Email: cansua05@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Regular menstrual cycles (21-35 days over the last three cycles)
- Age 18 years or older
- No medical treatment for PMS
- Ability to communicate effectively in Turkish
- No psychiatric diagnosis or gynecological disorder (e.g., abnormal uterine bleeding, myoma, ovarian cysts)
- A score >89 on the Premenstrual Syndrome Scale (PMSS)
- No prior participation in guided imagery training
Exclusion Criteria:
- Failure to perform guided imagery at the correct time or in the prescribed manner
- Irregular menstruation during the last three months
- Use of contraceptives
- Use of analgesics during menstruation while participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: intervention group
At baseline, students in both the intervention and control groups will complete the Introductory Characteristics Data Collection Form, the Premenstrual Syndrome Scale, and the WHO Quality of Life Scale. Students in the intervention group with high PMS scores will be instructed to practice guided imagery for 15 minutes daily during two consecutive menstrual cycles-specifically, during the seven days prior to menstruation when symptoms begin and the first four days of menstruation. The control group will receive no intervention. Throughout the study, intervention group participants will complete the Menstrual Cycle Follow-up Form and the Guided Imagery Follow-up Form, while control group participants will complete only the Menstrual Cycle Follow-up Form. After two cycles, both groups will again complete the Premenstrual Syndrome Scale and the WHO Quality of Life Scale. |
Guided imagery is a form of mind-body communication, defined as a flow of thoughts involving what we smell, taste, see, hear, and touch, or as the way the mind encodes, stores, and retrieves information.
Guided imagery is based on the understanding that the mind and body are interconnected and that the mind can influence bodily functions.
Stress and anxiety directly affect the brain and the immune system.
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No Intervention: control group
At baseline, students in both the intervention and control groups will complete the Introductory Characteristics Data Collection Form, the Premenstrual Syndrome Scale, and the WHO Quality of Life Scale.
No intervention will be applied to the control group; however, they will be asked to complete the Menstrual Cycle Follow-up Form throughout the study.
After two menstrual cycles, both groups will again complete the Premenstrual Syndrome Scale and the WHO Quality of Life Scale.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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premenstrual syndrome
Time Frame: two months
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The Premenstrual Syndrome Scale, developed by Gençdoğan (2006), is a five-point Likert-type instrument consisting of 44 items designed to assess the severity of premenstrual symptoms, based on DSM-III and DSM-IV-R criteria.
In scoring, responses are rated as follows: "None" = 1 point, "Very little" = 2 points, "Sometimes" = 3 points, "Often" = 4 points, and "Always" = 5 points.
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two months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA24/415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Scholarly database
Information comments: WHOQOL Group. Development of the WHOQOL-BREF quality of life assessment. Psychol Med. 1998;28(3):551-8. doi:10.1017/s0033291798006667.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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