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IRCT20250804066759N1 IRCT 2025-09-16 Shahre-kord University of Medical Sciences Evaluating The Effectiveness of Acceptance and Commitment Therapy on Sexual Function, Sexual Quality of Life, and Marital Intimacy Evaluating The Effectiveness of Acceptance and Commitment Therapy on Sexual Function, Sexual Quality of Life, and Marital Intimacy After Childbirth in Women Attending Comprehensive Health Centers 2025-09-06 anticipated 50 Complete https://irct.ir/trial/85364 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Since The Possibility Of Participant Influence In Group Sessions Is One Of The Common Challenges In Group-Based Interventions, A Specialist Psychologist Will Be Present In All Group Training Sessions Alongside The Researcher. This Is Planned To Manage The Situation By Guiding Discussions, Controlling Interactions, And Preventing Dominance Of Individual Opinions, Thereby Reducing Potential Side Effects, Randomization description: Participants Who Meet The Inclusion Criteria Will Be Recruited Using A Convenience Sampling Method. Initially, All Eligible Individuals Will Complete The Female Sexual Function Index (FSFI) Questionnaire. Those Who Score Below The Cutoff Point Of 28 On The FSFI Will Be Randomly Assigned To Either The Intervention Group Or The Control Group, With 25 Participants In Each Group. For The Purpose Of Randomization, 25 Cards Labeled "A" And 25 Cards Labeled "B" Will Be Thoroughly Mixed And Placed In An Envelope. Each Participant Will Randomly Draw One Card From The Envelope. The Label On The Selected Card Will Determine The Participant’s Group Allocation (A = Intervention Group, B = Control Group). N/A Condition 1: Sexual Function. Condition 2: Sexual Quality of Life. Condition 3: Marital Intimacy. Intervention 1: Intervention group: Members Of The Intervention Group Will Participate In Eight Weekly 90-Minute Sessions Of Acceptance And Commitment Therapy (ACT). This Intervention Will Be Designed And Implemented Based On The Standard ACT Protocol To Teach The Core Principles Of The Approach In A Structured, Step-By-Step Manner. In Each Session, One Of The Main Components Of ACT, Tailored To Postpartum Needs And Challenges, Will Be Taught By The Researcher And The Team’s Psychologist. The Topics Of Sessions One Through Eight Are As Follows: Introduction And Treatment Guidelines, Behavioral Change And Mindfulness, Acceptance And Values, Values Clarification, Cognitive Defusion, Committed Action, Acceptance With Suffering, And Conclusion And Wrap-Up. For Each Session, Related Homework Assignments Will Be Given, And Their Completion Will Be Reviewed By The Researcher In Subsequent Sessions. It Should Be Noted That Prior To The Intervention, Participants Will Complete The Study’s Questionnaires As A Pretest, And Ten Days After The Final Session, They Will Complete The Same Instruments As A Posttest To Enable The Comparison And Analysis Of Pre- And Posttest Scores. Intervention 2: Control group: During The 8-Week Intervention Period For The Intervention Group, The Control Group Will Not Receive Any Additional Intervention And Will Continue Their Routine Activities Without Participating In The Intervention Sessions Conducted By The Research Team. Before The Intervention Begins, Participants In The Control Group Will Also Complete The Research Questionnaires As A Pre-Test. Then, Ten Days After The Final Session, They Will Complete The Same Instruments As A Post-Test In Order To Allow For Comparison And Analysis Of Pre- And Post-Test Scores. In Observance Of The Right To Access Treatment, After Completing The Final Questionnaire, Audio Files Of The Sessions Will Be Provided Free Of Charge To All Members Of 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 No Further Information Is Available
public Shiva Alizadeh
Faculty Of Nursing And Midwifery, Shahrekord University of Medical Sciences , Rahmatieh
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3334 1216 shiivaalizadeh7@gmail.com Shahre-kord University of Medical Sciences scientific Farank Safdari DehCheshmeh
Faculty Of Nursing And Midwifery, Shahrekord University of Medical Sciences , Rahmatieh
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3334 1216 faranaksafdari@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Having Informed Consent to Participate in the Study Being Married Being Sexually Active (At Least Within the Past 4 Weeks) Having Passed a Minimum of 2 Months and a Maximum of 6 Months Since Childbirth Continuation of Exclusive Breastfeeding No History of Diagnosed Psychological Disorders in the Past 6 Months No Chronic or Acute Physical or Psychological Illnesses (Such as Diabetes, Hypertension, Severe Genitourinary Infections, Sudden Pelvic Injuries, Fractures, Stroke) That, in the Judgment of the Research Team, May Interfere With the Implementation of the Intervention or the Assessment of Its Outcomes No History of Cosmetic Surgery in the Genital Area Not Currently Receiving Any Concurrent Psychological Interventions No Addiction to Cigarettes, Hookah, or Similar Substances 18 years 49 years Female Pregnancy Occurrence of Any Stressful Life Event (Such as the Death of First-Degree Relatives) In The Past 6 Months Any Medication That May Significantly Affect Sexual Function or Psychological Status, Such as Antidepressants, Anticonvulsants, or Hormonal Medications Treatment - Other Other Intervention group: Members Of The Intervention Group Will Participate In Eight Weekly 90-Minute Sessions Of Acceptance And Commitment Therapy (ACT). This Intervention Will Be Designed And Implemented Based On The Standard ACT Protocol To Teach The Core Principles Of The Approach In A Structured, Step-By-Step Manner. In Each Session, One Of The Main Components Of ACT, Tailored To Postpartum Needs And Challenges, Will Be Taught By The Researcher And The Team’s Psychologist. The Topics Of Sessions One Through Eight Are As Follows: Introduction And Treatment Guidelines, Behavioral Change And Mindfulness, Acceptance And Values, Values Clarification, Cognitive Defusion, Committed Action, Acceptance With Suffering, And Conclusion And Wrap-Up. For Each Session, Related Homework Assignments Will Be Given, And Their Completion Will Be Reviewed By The Researcher In Subsequent Sessions. It Should Be Noted That Prior To The Intervention, Participants Will Complete The Study’s Questionnaires As A Pretest, And Ten Days After The Final Session, They Will Complete The Same Instruments As A Posttest To Enable The Comparison And Analysis Of Pre- And Posttest Scores. Control group: During The 8-Week Intervention Period For The Intervention Group, The Control Group Will Not Receive Any Additional Intervention And Will Continue Their Routine Activities Without Participating In The Intervention Sessions Conducted By The Research Team. Before The Intervention Begins, Participants In The Control Group Will Also Complete The Research Questionnaires As A Pre-Test. Then, Ten Days After The Final Session, They Will Complete The Same Instruments As A Post-Test In Order To Allow For Comparison And Analysis Of Pre- And Post-Test Scores. In Observance Of The Right To Access Treatment, After Completing The Final Questionnaire, Audio Files Of The Sessions Will Be Provided Free Of Charge To All Members Of The Control Group. Sexual Function Score On The Rosen's Standard Female Sexual Function Index Questionnaire. Timepoint: Before The Start Of The Intervention, And Ten Days After The End Of The Intervention. Method of measurement: Rosen's Standard Female Sexual Function Index Questionnaire. Sexual Quality Of Life Score On Symonds' Sexual Quality Of Life-Female (SQOL-F) Questionnaire. Timepoint: Before The Start Of The Intervention, And Ten Days After The End Of The Intervention. Method of measurement: Symonds' Sexual Quality Of Life-Female (SQOL-F) Questionnaire. Marital Intimacy Score On Thompson And Walker's Marital Intimacy Questionnaire. Timepoint: Before The Start Of The Intervention, And Ten Days After The End Of The Intervention. Method of measurement: Thompson And Walker's Marital Intimacy Questionnaire. Shahrekord University of Medical Sciences Approved 2025-08-02 Ethics Committee of Shahrekord University of Medical Sciences Central Administration Building, Shahrekord University of Medical Sciences and Health Services, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)