Comparative investigation between the effectiveness of Dry Ovarian Uterine Cupping and counselling with Mindfulness-Based Cognitive Therapy approach (MBCT) on women’s conception rate with Poly-Cystic Ovary Syndrome
Comparative investigation between the effectiveness of Dry Cupping and counselling with Mindfulness-Based Cognitive Therapy approach (MBCT) on women’s conception rate with Poly-Cystic Ovary Syndrome
Design
A clinical trial consisting of two intervention groups and a control group, with parallel groups, on 75 patients. Random allocation software is used for randomization.
Settings and conduct
intervention group with dry cupping: they are referred to Hakim Emadeddin Shirazi Iranian Medical Center in Shiraz.
counseling group with a mindfulness-based cognitive therapy approach: eight sessions of 120 to 150 minutes of counseling will be held by the researcher.
This study has no blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Married infertile women with a definitive diagnosis of PCOS based on Rotterdam criteria that were diagnosed by the gynecologists
2- Patients should be between 18 to 40 years old
3- Being married
4- Ability to read, write and speak Persian
5- agreement of couples to have vaginal quietus (for example, 2-3 times per week) around the time of ovulation during the study.
Criteria for not entering:
1- Endometrial, cervical, breast or ovarian cancers
2- History of deep vein thrombosis or pulmonary embolism
3- Having known mental illnesses under treatment
4- Using psychotropic drugs and narcotics
5- Having another endocrine, internal or chronic diseases affecting conception rate
Intervention groups
1- Dry cupping treatment group: Dry cupping under the abdomen in the upper pubic area is done with three special glasses in clean days, twice a week for two months
2- Counselling group with a mindfulness-based cognitive therapy approach including eight sessions of 120 to 150 minutes per week
3- Control group: no intervention.
Main outcome variables
conception rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N13
Registration date:2021-11-05, 1400/08/14
Registration timing:prospective
Last update:2021-11-05, 1400/08/14
Update count:1
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation between the effectiveness of Dry Ovarian Uterine Cupping and counselling with Mindfulness-Based Cognitive Therapy approach (MBCT) on women’s conception rate with Poly-Cystic Ovary Syndrome
Public title
Comparative investigation between the effectiveness of Dry Cupping and counselling with Mindfulness-Based Cognitive Therapy approach (MBCT) on women’s conception rate with Poly-Cystic Ovary Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women with infertility with definitive diagnosis of polycystic ovary syndrome based on Rotterdam criteria by gynecologists
Lack of known mental illnesses under treatment
Do not use psychotropic drugs and narcotics
Married women
Ability to read, write and speak Persian
Do not attend counseling sessions or medication for fertility
Couples agree to have vaginal sex (for example, two to three times a week) around the time of ovulation during the time of the study
No endometrial cancer or cervical cancer
The subject should not have a history of deep vein thrombosis or pulmonary embolism
Exclusion criteria:
ٍEndocrine, endogenous or any chronic diseases affecting the rate of fertilization
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Entrants are randomly divided into three groups of 25 using Random allocation software and creating six blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences / Pardizeh / School of Nursing and Midwifery
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.KMU.REC.1400.290
Health conditions studied
1
Description of health condition studied
infertile women due to poly cystic ovary syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Conception rate
Timepoint
Fertilization rate will assess based on Beta HCG test in all three groups(if delayed menstruation occurs) at four times: immediately after treatment, one month after treatment, two months after treatment, three months after treatment.
Method of measurement
Beta HCG test
Secondary outcomes
1
Description
Changes in Luteinizing hormone
Timepoint
At four times: immediately after the end of treatment, one month after the end of treatment, two months after the end of treatment, three months after the end of treatment
Method of measurement
Luteinizing hormone test
Intervention groups
1
Description
In Intervention group, dry cupping therapy is performed by three special glasses twice a week for two months during the cleansing period .The dry cupping will put under the abdomen in the upper pubic area . The glasses or cups for cupping have 5 sizes that are selected according to the size of the individual. The person is placed on the bed lying on his back and where the cupping is performed is exposed. The first cup is placed above the pubis symphysis or four fingers below the umbilicus. The other two glasses are placed to the right and left of the first glass at a distance of about 2.5 cm, and again their distance to the umbilicus of four fingers is closed. The end of the cups is connected to the suction device. The body is sucked towards the top of the glass and becomes red and full of blood. The glasses remain for seven minutes and then the suction is cut off and the cups are gently removed . In fact, 12 sessions of cupping therapy should be performed in two months. All members of this group were referred to Hakim Emadeddin Shirazi Health Center of Iranian Medicine in Shiraz for cupping and were performed by a trained minister under the supervision of a traditional medicine specialist.
Category
Treatment - Other
2
Description
Intervention group: Counseling group with Mindfulness-Based Cognitive Therapy approach (MBCT):In this group, eight sessions will be held for 120 to 150 minutes with 45 minutes a day of exercise, which can be accompanied by a one-day mind-guided program in 6th week. In the first 4 sessions, the focus is on inner experiences and in the second half is on life challenges. All sessions begin with a formal exercise (body checking, mindfulness movement, or sitting meditation practice).Short mindfulness exercises, such as three-minute breathing and conscious walking, are poems and stories related to the topic of the session, and there will also be a short mindfulness exercise at the end of each session. If the prevalence of Covid19 is not low at the time of the intervention, counseling sessions will be held on-line. The summary of counseling protocol with mindfulness-based cognitive therapy approach to increase pregnancy rate in patients with polycystic ovary syndrome is as follows: session1: Mind autopilot: basic acquaintance, stating the purpose of group formation, stating the rules and restrictions of the sessions / defining research variables, raisin technique / body meditation. Homework: 45 minute body meditation, and mindfulness on a daily task And a meal. session2: Overcoming Obstacles: Body Check Meditation, Ten Minutes of Mindful Breathing, Mindfulness Techniques on Thoughts and Feelings Homework: 45-Minute Body Check Meditation, Ten Minutes of Mindful Breathing, and Mindfulness of Another Daily Task, Daily Record of One Experience Pleasant event.session3:Mindfulness of breathing and body while moving: Conscious movement technique, conscious seeing and hearing practice, then stretching and breathing practice and then sitting meditation with body and breathing awareness, three-minute breathing space technique Explore the calendar of pleasant experiences (from week 4) Then it can be accompanied by a calendar of unpleasant experiences.) Homework: Practice stretching and breathing on the first, third and fifth days, practice mindful movement on the second, fourth and sixth days, record an unpleasant event, three-minute breathing space technique Times a day.session4: Session 4: Staying in the present: 5 minutes mind awareness of seeing or hearing, sitting meditation (awareness of breathing, body, sounds, thoughts and consciousness without choice), three-minute breathing space technique and using it when a coping skill when you feel like life is going hard, conscious walking, exploring the calendar of unpleasant experiences with defining the realm of stress Homework: sitting meditation, three-minute breathing space technique with regard to it as a coping skill In any unpleasant feeling.session5: Acceptance and permission. Sitting meditation with awareness on breathing and body, emphasizing how we react to thoughts, feelings, five senses when they occur, introducing problems in mindfulness exercises and exploring its effects on body and mind, three-minute breathing space , Reading a mindfulness-based poem and exploring its themes in the group, exploring habitual patterns of reaction and the potential to use mindfulness skills to facilitate more responsiveness to the experience of the present and the moment of homework: a three-minute breathing space technique with consideration Take it as a coping skill in any unpleasant feeling) and then explore the choice of opening the body gate. session6:Thoughts are not reality: sitting meditation with awareness on breathing and body along with introducing problems in mindfulness exercises and exploring its effects on body and mind, three-minute breathing space, practicing moods, alternative thoughts and perspectives, starting to develop an action plan and Individual validation of mindfulness on home stress-solving: forty-minute exercises a day, working with different combinations of the three main bases of exercises; Use short exercises, exercises with or without CDs, three-minute breathing space (regular three times a day), three-minute breathing space (adaptation during each unpleasant event) and in the first stage, creating a wider view of thoughts, practice Open in thinking, reflection and more work on preventing stress recurrence, action plan.session7:How can I best take care of myself? Sitting meditation with awareness on breathing and body, sounds, thoughts and feelings, three-minute breathing space of the body with the introduction of problems in mindfulness exercises and exploring its effects on body and mind, exploring the relationship between behavior and mood, preparing a list of activities Daily and check which activity creates a feeling of emptiness and which a feeling of strengthening and vitality and dominance. Efforts to increase strengthening activities. Identify signs of recurrence of stress symptoms to deal with possible recurrence. Homework: Perform one of the activities that the person can continue after the sessions. Breathing-Regular and Coping Space: After practicing exploring the choice of opening in skillful performance, consider and create a warning system to detect the recurrence of stress as well as an action plan in times when mood swings. session8: Apply the fact learned in the face of the future: Examining body care, final care, reviewing early warning systems and planning for use at times of high recurrence, reviewing the entire course - the most valuable things in your life that mindfulness exercises do to you in times of encounter Help them continue with the formal and informal exercises they have learned in life .Homework: Plan to continue the exercises in the follow-up period
Category
Behavior
3
Description
Control group: In the control group, no intervention is performed, but after the end of the study, if the people wish, a counseling package is given to them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Specialized and Sub-Specialized Clinic
Full name of responsible person
Mani Ramzi
Street address
Shahid Motahari Specialized and Sub-Specialized Clinic, next to Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13111
Phone
+98 71 3612 1000
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir
Web page address
https://motahari.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Fax
+98 34 3132 5829
Email
international@kmu.ac.ir
Web page address
http://kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
a.ahmadi@kmu.ac.ir
Web page address
http://kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
a.ahmadi@kmu.ac.ir
Web page address
http://kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
a.ahmadi@kmu.ac.ir
Web page address
http://kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD