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IRCT20251017067664N1 IRCT 2025-11-03 Arak University of Medical Sciences Effect of Mindfulness-Based Counseling on Back Pain During Pregnancy Investigating the Effect of Mindfulness-Based Counseling on the Perception of Back Pain in Primiparous Pregnant Women 2025-12-01 anticipated 40 Complete https://irct.ir/trial/87194 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, block randomization was used to allocate pregnant women to the intervention and control groups. The unit of randomization was individual, meaning each participant was separately assigned to one of the two groups. Block sizes of 4 and 6 were used to maintain balance in the number of participants across groups. The randomization sequence was generated using R statistical software. The allocation sequence was produced by the statistical consultant, and group codes (A and B) were randomly assigned. To prevent selection bias, sequentially numbered, opaque, sealed envelopes (SNOASE) were used. Each envelope contained the allocation code (A or B). After a qualified participant entered the study, the next envelope in numerical order was opened. Thus, the researcher remained unaware of the participant's group until the moment of allocation, ensuring full allocation concealment. N/A Backpain. Intervention 1: Intervention Group: The intervention is developed based on the mindfulness techniques training protocol by Williams and Penman (2011) and consists of 8 group educational sessions lasting 90 minutes each (in groups of 10 individuals). The sessions are conducted by the researcher (who has completed a mindfulness-based counseling training course) in the training hall of urban comprehensive health centers in Khorramabad County. Training is delivered using techniques such as question-and-answer, role-playing, in-class and homework assignments, and is grounded in exercises including reflection, body scan, mindfulness meditation, and mindful breathing. The detailed content of each session is as follows:Session 1 (Introduction and Foundation):Introduction to the objectives, structure, and rules of the sessions;Administering pre-test (McGill Pain Questionnaire MPQ and Visual Analog Scale VAS);Presenting the history of each participant;Explaining the concepts of pregnancy, back pain, mindfulness, and its effects on life;Teaching deep breathing (focusing on inhalation and exhalation) with practical implementation;Emphasizing repetition of the exercise in each session;Obtaining feedback from participants;Emphasizing the importance of homework;Distributing specialized educational booklets for pregnant women.Session 2 (Practicing Presence in the Moment):Reviewing homework and obstacles (such as mind wandering);Emphasizing persistence in mindfulness practices;Teaching seated body scan (practical implementation);Teaching mindfulness in daily activities (mindful attention to routine tasks);Homework: Daily body scan practice and mindfulness in one simple activity.Session 3 (Living in the Moment):Reviewing homework;Exercises for seeing and hearing in the present moment (exercise "now – here");Performing the raisin eating exercise with full mindfulness;Repeating the seated body scan;Teaching mindful walking;Homework: Mindful walking practice and daily body scan.Session 4 (Stress Management):Reviewing homework;Defining stress and why negative memories are highlighted;Visualizing a pleasant event;Awareness of daily unpleasant events;Homework: Daily recording of one pleasant and one unpleasant event.Session 5 (Acceptance Without Judgment):Reviewing homework;Examining ways to avoid bad moods;Emphasizing non-attachment to positive and negative events;Performing the three-minute breathing exercise (space, body, breath);Homework: Daily three-minute breathing practice.Session 6 (Distinguishing Thoughts and Emotions):Reviewing homework;Distinguishing thoughts, emotions, and feelings (especially in pregnancy and childbirth);Expressing participants' thoughts and emotions in the pregnancy domain;Teaching mindful confrontation with negative thoughts;Practicing focus on breathing;Homework: Recording thoughts related to back pain and mindfulness practice.Session 7 (Pleasurable Activities):Reviewing homework;Performing body check exercise;Preparing a list of pleasurable activities for the coming week;Homework: Performing at least 3 pleasurable activities and recording their effect on pain.Session 8 (Consolidation and Closure):Reviewing homework and body scan;Overall review of all sessions and learned skills;Planning for continuing a mindful lifestyle;Adapting exercises to pregnancy conditions;Administering post-test (MPQ and VAS);Providing the complete session content in PDF format to the control group at the end of the study. Intervention 2: Control Group: The control group receives no mindfulness-based educational or counseling intervention and is only under routine pregnancy care (including regular midwifery visits, weight and blood pressure monitoring, routine laboratory tests, and standard health center education on nutrition, physical activity, and pregnancy warning signs). The McGill Pain Questionnaire (MPQ) and Visual Analog Scale (VAS) are completed by the control group in three stages (before the start of the intervention, immediately after the completion of the 8 intervention sessions in the opposite group, and 6 months after the intervention). At the end of the study and after collecting the final data, the complete content of the 8 educational sessions (including booklets, exercises, and guided audio files) is provided in PDF format to the members of the control group to ensure ethical fairness and allow them to benefit from the intervention as well. No educational contact, group session, or homework is planned for the control 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 Undecided - It is not yet known if there will be a plan to make this available
public Foroozan Morovati
Shahid Shiroudi street
Arak Iran (Islamic Republic of) 9878767698 +98 86 3277 7400 airsagostar2008@gmail.com Arak University of Medical Sciences scientific Forozan Morovati
No.16، Yasaman Alley ، 30 meters from Pajouhandeh ، Razi Street
Khorramabad Iran (Islamic Republic of) 8765764536 +98 66 3320 4756 f.morovati@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Women are primiparous. They are in weeks 24 to 26 of pregnancy. They have an electronic health record in the SIB system at urban health centers in Khorramabad. They score 3 to 4 on the Visual Analog Scale (VAS) for pain. They provide informed consent to participate in the study. Singleton pregnancy 18 years 40 years Female History of back pain before pregnancy History of chronic musculoskeletal or spinal diseases Presence of pregnancy complications such as high blood pressure, bleeding, or placenta previa History of chronic diseases such as diabetes or heart disease History of recurrent miscarriage or high-risk pregnancy Regular exercise before pregnancy Education or employment in psychology or counseling fields Employment in heavy work or continuous lifting of heavy objects Severe obesity (very high BMI) Diagnosed mental disorders or use of psychiatric medications M54.5 Low back pain Other Other Intervention Group: The intervention is developed based on the mindfulness techniques training protocol by Williams and Penman (2011) and consists of 8 group educational sessions lasting 90 minutes each (in groups of 10 individuals). The sessions are conducted by the researcher (who has completed a mindfulness-based counseling training course) in the training hall of urban comprehensive health centers in Khorramabad County. Training is delivered using techniques such as question-and-answer, role-playing, in-class and homework assignments, and is grounded in exercises including reflection, body scan, mindfulness meditation, and mindful breathing. The detailed content of each session is as follows:Session 1 (Introduction and Foundation):Introduction to the objectives, structure, and rules of the sessions;Administering pre-test (McGill Pain Questionnaire MPQ and Visual Analog Scale VAS);Presenting the history of each participant;Explaining the concepts of pregnancy, back pain, mindfulness, and its effects on life;Teaching deep breathing (focusing on inhalation and exhalation) with practical implementation;Emphasizing repetition of the exercise in each session;Obtaining feedback from participants;Emphasizing the importance of homework;Distributing specialized educational booklets for pregnant women.Session 2 (Practicing Presence in the Moment):Reviewing homework and obstacles (such as mind wandering);Emphasizing persistence in mindfulness practices;Teaching seated body scan (practical implementation);Teaching mindfulness in daily activities (mindful attention to routine tasks);Homework: Daily body scan practice and mindfulness in one simple activity.Session 3 (Living in the Moment):Reviewing homework;Exercises for seeing and hearing in the present moment (exercise "now – here");Performing the raisin eating exercise with full mindfulness;Repeating the seated body scan;Teaching mindful walking;Homework: Mindful walking practice and daily body scan.Session 4 (Stress Management):Reviewing homework;Defining stress and why negative memories are highlighted;Visualizing a pleasant event;Awareness of daily unpleasant events;Homework: Daily recording of one pleasant and one unpleasant event.Session 5 (Acceptance Without Judgment):Reviewing homework;Examining ways to avoid bad moods;Emphasizing non-attachment to positive and negative events;Performing the three-minute breathing exercise (space, body, breath);Homework: Daily three-minute breathing practice.Session 6 (Distinguishing Thoughts and Emotions):Reviewing homework;Distinguishing thoughts, emotions, and feelings (especially in pregnancy and childbirth);Expressing participants' thoughts and emotions in the pregnancy domain;Teaching mindful confrontation with negative thoughts;Practicing focus on breathing;Homework: Recording thoughts related to back pain and mindfulness practice.Session 7 (Pleasurable Activities):Reviewing homework;Performing body check exercise;Preparing a list of pleasurable activities for the coming week;Homework: Performing at least 3 pleasurable activities and recording their effect on pain.Session 8 (Consolidation and Closure):Reviewing homework and body scan;Overall review of all sessions and learned skills;Planning for continuing a mindful lifestyle;Adapting exercises to pregnancy conditions;Administering post-test (MPQ and VAS);Providing the complete session content in PDF format to the control group at the end of the study. Control Group: The control group receives no mindfulness-based educational or counseling intervention and is only under routine pregnancy care (including regular midwifery visits, weight and blood pressure monitoring, routine laboratory tests, and standard health center education on nutrition, physical activity, and pregnancy warning signs). The McGill Pain Questionnaire (MPQ) and Visual Analog Scale (VAS) are completed by the control group in three stages (before the start of the intervention, immediately after the completion of the 8 intervention sessions in the opposite group, and 6 months after the intervention). At the end of the study and after collecting the final data, the complete content of the 8 educational sessions (including booklets, exercises, and guided audio files) is provided in PDF format to the members of the control group to ensure ethical fairness and allow them to benefit from the intervention as well. No educational contact, group session, or homework is planned for the control group. Change in total McGill Pain Questionnaire (MPQ) score from baseline to immediately post-intervention. Timepoint: Baseline (pre-intervention), immediately after the last intervention session, and 6 months post-intervention. Method of measurement: McGill Pain Questionnaire. Change in total McGill Pain Questionnaire (MPQ) score from baseline to 6 months post-intervention. Timepoint: Baseline (pre-intervention), immediately after the last intervention session, and 6 months post-intervention. Method of measurement: McGill Pain Questionnaire. Arak University of Medical Sciences Approved 2025-09-07 Ethics committee ofArak University of Medical Sciences Shahid Shiroudi street Arak Markazi Iran (Islamic Republic of)