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IRCT20200107046044N5 IRCT 2025-06-09 Yasouj University of Medical Sciences A Comparative Study of the Impact of Progressive Muscle Relaxation and Mindfulness Artificial Intelligence-Based on Fatigue Levels and Pain Intensity A Comparative Study of the Impact of Progressive Muscle Relaxation and Mindfulness Artificial Intelligence-Based on Fatigue Levels and Pain Intensity in Women Suffering from Polycystic Ovary Syndrome: A randomized controlled trial 2025-07-23 anticipated 72 Complete https://irct.ir/trial/84160 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block random assignment will be done in such a way that according to the number of study groups (three groups) consisting of intervention 1 (Progressive Muscle Relaxation), intervention 2 (Mindfulness) and control and calculated based on the factorial law, i.e. 3!= 3×2×1= 6, all the possible arrangement modes of people will be compiled based on the table below, considering A for intervention group 1 (Progressive Muscle Relaxation), B for intervention group 2 (Mindfulness) and C for control group: 1 2 3 4 5 6 ABC ACB BAC BCA CAB CBA Then, since the estimated sample size was 99 people, in each block, three samples, each representative of a study group and their arrangement order was also different, from these blocks, placement sampling will be done. After the study objectives are fully explained, eligible research samples will be selected and, based on the time priority of referral, each of them will be assigned a code. By matching that number with the block random allocation list, the patients participating in the study will be assigned to one of the intervention 1 (Progressive Muscle Relaxation), intervention 2 (Mindfulness), and control groups. This process will continue until the estimated sample size is completed. N/A Polycystic Ovary Syndrome. Intervention 1: Intervention Group 1: Progressive Muscle Relaxation (PMR): In this group, the patient is placed in a lying down and comfortable position. On the first day, the relaxation training includes the following steps: identifying the target muscles, demonstrating and explaining the relaxation technique by the researcher, and practicing the technique under the researcher's supervision according to the protocol. Once patients are fully capable of performing the technique, they will repeat it every night at home before sleep. The researcher will follow up on their adherence at home. After the initial training by the researcher, the interventions will be carried out individually by the patients at home. The intervention consists of 8 sessions, each lasting 1 hour, held once a week over a period of 8 weeks. Prior to the start of the interventions, the artificial intelligence program, including ChatGPT, will be introduced to the participants by the researcher. The researcher will fully explain how to use these tools, including initial training, guidance, and troubleshooting any technical issues. As such, in the event of any questions, participants will refer only to these smart tools to find their answers. The intervention protocol will also be selected and implemented using the mentioned AI tools. Intervention 2: Intervention Group 2: MindfulnessThis group will undergo an 8-session mindfulness protocol as outlined below: Session 1: Introduction of participants and a brief overview of the 8 sessions. Raisin-eating exercise, followed by a 30-minute body scan meditation and discussion about the feelings experienced during the practice. Session 2: Body scan meditation and discussion of the experience. Seated meditation practice. Session 3: Practicing awareness and focus on emotions. Paying attention to the present moment, breathing, and body sensations. Three-minute breathing space exercise. Session 4: Breathing-focused meditation. Practicing the expression and listening of one’s own emotions. Session 5: Meditation practice. Practicing self-acceptance and acceptance of one’s emotions. Session 6: Breathing space practice. Practicing non-judgmental awareness of emotions and events. Session 7: Meditation focused on awareness of anything that enters consciousness in the present moment. Session 8: Review of experiences and implementation of the post-test.A follow-up phone call will be made to monitor the continuation of home practice. After the initial training by the researcher, the interventions will be carried out individually by the patients at home.The intervention includes 8 sessions, each lasting 1 hour, conducted once a week over a period of 8 weeks, in accordance with similar studies.Before the start of the intervention, artificial intelligence tools, including ChatGPT, will be introduced to the participants by the researcher. The researcher will provide full instructions on how to use these tools, including initial training, guidance, and troubleshooting of any technical issues. Consequently, if any questions arise, participants will only refer to these smart tools to find their answers. The intervention protocol will also be selected and implemented using the aforementioned AI tools. Intervention 3: Control group: non-intervention: There will be no intervention in this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public MohammadSajjad Mousavi
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
Bandar-e-Mahshahr Iran (Islamic Republic of) 6354169401 +98 61 5242 1065 sajjad.mousavi2512@gmail.com Ahvaz University of Medical Sciences scientific MohammadSajjad Mousavi
Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran
Bandar-e-Mahshahr Iran (Islamic Republic of) 6354169401 +98 61 5242 1065 sajjad.mousavi2512@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Ability to communicate and respond to the Multidimensional Fatigue Inventory and Visual Analogue Scale Age between 18 and 40 years Willingness to participate in the study and signing the informed consent form Definitive diagnosis of polycystic ovary syndrome by the relevant specialist physician Scoring 60 or above on the Multidimensional Fatigue Inventory Having chronic pain or similar symptoms such as lower abdominal pain or pain caused by ovarian issues No prior training or participation in studies similar to the current research within the past 6 months 18 years 40 years Female Not meeting the inclusion criteria Presence of severe psychological disorders (such as major depression or severe anxiety) requiring specialized treatment Physical or mental disabilities—individuals who, due to their condition, are unable to perform relaxation or mindfulness exercises Use of sleeping pills, anti-anxiety, or antidepressant medications prior to the intervention Worsening of symptoms and the need for immediate medical treatment E28.2 Polycystic ovarian syndrome Lifestyle Lifestyle Lifestyle Intervention Group 1: Progressive Muscle Relaxation (PMR): In this group, the patient is placed in a lying down and comfortable position. On the first day, the relaxation training includes the following steps: identifying the target muscles, demonstrating and explaining the relaxation technique by the researcher, and practicing the technique under the researcher's supervision according to the protocol. Once patients are fully capable of performing the technique, they will repeat it every night at home before sleep. The researcher will follow up on their adherence at home. After the initial training by the researcher, the interventions will be carried out individually by the patients at home. The intervention consists of 8 sessions, each lasting 1 hour, held once a week over a period of 8 weeks. Prior to the start of the interventions, the artificial intelligence program, including ChatGPT, will be introduced to the participants by the researcher. The researcher will fully explain how to use these tools, including initial training, guidance, and troubleshooting any technical issues. As such, in the event of any questions, participants will refer only to these smart tools to find their answers. The intervention protocol will also be selected and implemented using the mentioned AI tools. Intervention Group 2: MindfulnessThis group will undergo an 8-session mindfulness protocol as outlined below: Session 1: Introduction of participants and a brief overview of the 8 sessions. Raisin-eating exercise, followed by a 30-minute body scan meditation and discussion about the feelings experienced during the practice. Session 2: Body scan meditation and discussion of the experience. Seated meditation practice. Session 3: Practicing awareness and focus on emotions. Paying attention to the present moment, breathing, and body sensations. Three-minute breathing space exercise. Session 4: Breathing-focused meditation. Practicing the expression and listening of one’s own emotions. Session 5: Meditation practice. Practicing self-acceptance and acceptance of one’s emotions. Session 6: Breathing space practice. Practicing non-judgmental awareness of emotions and events. Session 7: Meditation focused on awareness of anything that enters consciousness in the present moment. Session 8: Review of experiences and implementation of the post-test.A follow-up phone call will be made to monitor the continuation of home practice. After the initial training by the researcher, the interventions will be carried out individually by the patients at home.The intervention includes 8 sessions, each lasting 1 hour, conducted once a week over a period of 8 weeks, in accordance with similar studies.Before the start of the intervention, artificial intelligence tools, including ChatGPT, will be introduced to the participants by the researcher. The researcher will provide full instructions on how to use these tools, including initial training, guidance, and troubleshooting of any technical issues. Consequently, if any questions arise, participants will only refer to these smart tools to find their answers. The intervention protocol will also be selected and implemented using the aforementioned AI tools. Control group: non-intervention: There will be no intervention in this group. The fatigue score is derived from the Multidimensional Fatigue Inventory. Timepoint: Before and after the interventions. Method of measurement: Multidimensional Fatigue Inventory. Pain score based on Visual Analogue Scale. Timepoint: Severity of pain before, during and after the intervention. Method of measurement: Visual Analogue Scale. Yasouj University of Medical Sciences Approved 2025-06-03 Ethics committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)