Pregnancy RelatedNCT06422780
Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women
A study testing Maternal Role Preparation Training and Awareness Centred Occupational Therapy Group in people with Pregnancy Related and Postpartum Complication, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare maternal role preparation and mindfulness-centred occupational therapy trainings in pregnant women: a randomised controlled trial with postpartum follow-up. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Postpartum Complication
- What is being tested?
- Maternal Role Preparation Training and Awareness Centred Occupational Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 years of age
- Having conceived naturally
- Being between 14-27 weeks of gestation
- To be literate
- Being primiparous
- Reading and understanding Turkish
Show all 11Show fewer
- Volunteering to participate in the study
- To have attended 80% of the trainings given
- Giving birth at term
- Having a healthy newborn (newborn born at 38-42 weeks of gestation, without low birth weight, without any disease)
- Providing active care to the newborn baby with or without assistance
Who cannot join
- Having a risky pregnancy (gestational diabetes, eclampsia, pre-eclampsia, threatened preterm birth, premature rupture of membranes, placental anomalies etc.)
- Having a maternal physical anomaly
- Communication difficulties and mental deficiency
- Having a medical history of mental illness
- Having a foetal abnormality during pregnancy
- Having a disease/complication that developed during pregnancy
Show all 10Show fewer
- Experiencing a traumatic event within 6-8 weeks postpartum (loss/death of a close person, natural disasters, accident, assault)
- Stillbirth or having a baby with anomalies
- Having a baby that requires an intensive care environment in a hospital
- Mothers diagnosed with psychiatric illness (schizophrenia, depression, anxiety, panic attacks)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çankırı Karatekin University Occupational Therapy Department
Çankırı, Çankırı, 18100
About this study
Official title: Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women: Randomised Controlled Trial With Postpartum Follow-up
The aim of this study was to compare maternal role preparation and mindfulness-centred occupational therapy trainings in pregnant women: a randomised controlled trial with postpartum follow-up.
Read the detailed description
Pregnancy and postpartum are a major change and crisis process for women. Women undergo hormonal, vascular, anatomical, physiological, and psychological changes for 40 weeks to meet the biochemical needs of the developing fetus, maintain homeostasis, and prepare for childbirth and lactation. These changes occurring during pregnancy are necessary to protect the health of mother and baby, as well as to prepare women for childbirth and maternity.
Psychological changes that vary from trimester to trimester, accompanied by physiological changes in pregnancy. Especially in the second and third trimester, changes in the biopsychosocial balance, affecting family and work roles, taking on new responsibilities, trying to adapt to new roles and meeting the baby increased perceived depression, anxiety and stress. These physiological and psychological symptoms during pregnancy have been to adversely affect the quality of life of pregnant women. In literature, participation in meaningful and purposeful activities, which is an important indicator of quality of life, is also believed to have an impact on occupational performance during pregnancy. During pregnancy, post-partum and postpartum, the mother is expected to adapt to the physiological and psychological changes she experiences, to be able to take care of herself and her baby, to play the role of mother and to accept her baby. Physical activity levels, sleep and quality of life during pregnancy are also likely to be affected by maternal role adaptation and participation in social life. In this context, it should be taken into account that the period of pregnancy is an important milestone for the end of childbirth and the postpartum period.
Postpartum physical problems occur in 70% of women, while 17% of women are accompanied by emotional problems.Especially in the postpartum period, emotional changes have been to occur in between 24% and 89% of women with post-partum depression (PPD), between 40% and 50% of mothers and between 9% and 30% of female with anxiety. Emotional problems can also arise as a result of a mother's physical problems, such as providing baby care, creating a safe environment for the baby, communicating with the child, learning new roles, developing family sensitivity, and dealing with problems related to the baby. Therefore, the postpartum period can become a crisis life for the family, just like pregnancy.Physical and emotional symptoms may adversely affect family, work, and social life, thereby reducing quality of life. (14,15,24). Physical and emotional symptoms have also been to negatively affect the maternal bond between the mother and the baby, the mother's sense of self, occupational balance, and occupational performance.
Occupational Theraphy is a health care profession that supports an individual's ability to sustain occupational performance through various interventions and person-centric practices, helping the individual to adapt to changes that are constantly encountered within and around him. In this context, one of the interventions used to enhance pregnancy coherence is maternal role preparation training. Maternal role preparation is an occupational training that focuses on improving motherhood competence and living a successful role-to-mother harmony when the mother becomes a mother for the first time.
One of the other interventions used in occupational therapy is a person-centric occupation therapy. In today's occupational therapy interventions, person-centric practices have always been a key element. With a person-centric approach, consultants and therapists work together to identify the nature of their occupational performance problems, the focus and need of the intervention, and the consequences of the preferred treatment.
In this context, the study was planned to study tangible behavioral changes resulting from interventions in healthy pregnant women and their impact on participation in daily life activities. Our study aims to study the effectiveness of maternal role preparation training and awareness-based occupational therapy and post-partum follow-up.
This study is important for the continuation of valuable activities and roles within pregnant women's daily routines, for the development of new strategies to make them feel better during pregnancy, and for a clinically integrated approach.
- Conditions
- Pregnancy Related, Postpartum Complication
- Being tested
- Maternal Role Preparation Training, Awareness Centred Occupational Therapy Group
- Keywords
- pregnancy, postpartum period, occupational therapy, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Role Preparation TrainingOther
Maternal Role Preparation Training: Maternal Role Preparation Training (MRHE) is an occupational training programme aimed at increasing the competence of first-time mothers regarding motherhood. In this four-session programme, pregnant women will be provided with written materials, face-to-face talks and practical training covering topics related to their babies (maternal attachment, training on the sensory and developmental abilities of babies) and themselves (training on adopting a new role as a mother).The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions.
Awareness Centred Occupational Therapy GroupOther
Awareness Centred Occupational Therapy (FME); In FME, areas that affect the occupational performance of pregnant women in their daily lives will be identified and appropriate occupational therapy interventions will be applied. Awareness training on the applications will be given before starting the sessions. The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. Awareness training will be given before starting the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Role Preparation Training Group | Active comparator | Pregnant women in the second trimester (14-27th week) will be included in the trainings. Receives: Other: Maternal Role Preparation Training |
| Awareness Centred Occupational Therapy Group | Active comparator | Pregnant women in the second trimester (14-27th week) will be included in the trainings. Receives: Other: Awareness Centred Occupational Therapy Group |
| Control Group | No intervention | Pregnant women in the second trimester (14-27th week) will be included in the trainings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nothingham Health Profile(NHP)
The Nottingham Health Profile will be used to assess the awareness of pregnant women about their own health status. The Nottingham Health Profile assesses self-perceived health status and includes subsections on pain, emotional reactions, sleep, social isolation, physical activity and energy. These sub-sections make up the more intensively used section 1, while work life, household chores, social life, home life, sexual life, interests and holidays make up section 2. Each section is scored on a scale of 0-100. In the sections consisting of questions answered yes and no, the highest score can be 0 and the lowest score can be 100 (40,41). Turkish adaptation was performed by Küçükdeveci et al. in 1997.
Measured: 3 weeks
Secondary outcomes (8)
Demographic Data Form
Physical, demographic and obstetric information of pregnant women will be recorded. In the physical information section, the height (m), body weight (kg) before pregnancy and at the time of assessment will be recorded. In the demographic information section, the age, marital status ("married" and "single"), educational status of the pregnant woman and the father, employment status ("working" and "not working") and occupation of the pregnant woman and the father will be questioned. Educational status will be recorded categorically as "only literate", "primary school", "secondary school", "high school", "associate degree", "bachelor's degree", "master's degree" and "doctorate"
Measured: 1 weeks
Occupational Balance Questionnaire(OBQ11-T)
The validity and reliability study of the Turkish version, developed by Wagman and Hakansson (2012), was carried out by Günal et al. (2019). The test-re-test reliability ratio for the Turkish version of the scale was 0.922, with the Cronbach alpha value being 0.785. The room is a self-reporting scale that evaluates a person's occupational balance in different dimensions. It is used to measure the satisfaction a person receives from the number and variety of daily activities and to determine the occupational balance based on the results obtained. The scale consists of 11 items rated at a 4-point range ranging from 0 (I totally disagree) to 3 (I absolutely agree). The scale's total score is the sum of the individual scores given to the questions and ranges from 0-33. High scores indicate a better occupational balance.
Measured: 3 weeks
Time Management Questionnaire(TMQ)
Time management of individuals will be evaluated by Time Management Questionnaire (TMQ) consisting of 27-items. Developed by Britton and Tesser (1991), Alay and Koçak (2002) conducted a Turkish reliability and validity study. The reliability coefficient calculated by Cronbach's alpha correlations was found to be 0.88 for Time Planning, 0.66 for Time Attitudes subscale and 0.87 for the whole scale. The ATI is an inventory with 3 subscales: 16-item Time Planning, 7-item Time Attitudes and 4-item Time Spenders. Each item is scored out of 5 and a five-point scale consisting of "always, often, sometimes, rarely and never" options is formed. In scoring, 5 is given to the answer at the end of the scale, while 1 is given to the answer on the other side of the scale. The maximum score that can be obtained from the RIQ is 135 and the minimum score is 27.
Measured: 3 weeks
The Hospital Anxiety and Depression Scale(HADS)
Hospital Anxiety and Depression Scale (HADS): HAD was developed by Zigmond and Snaith (47) in 1983. Turkish validity and reliability of the scale was performed by Aydemir in 1997. The scale consists of 14 items. Odd numbered items in the scale investigate anxiety and even numbered items investigate depression. Seven items measure anxiety and seven items measure depression. In the Turkish validity and reliability study of the scale, the cronbach alpha coefficient was found to be 0.85 for the anxiety subscale and 0.77 for the depression subscale. In this study, the cronbach alpha values of the scale sub-dimensions were found to be 0.88 for the anxiety sub-dimension and 0.79 for the depression sub-dimension.
Measured: 3 weeks
The Cognitive Emotion Regulation Questionnaire
It was developed by Garnefski, Kraaij, and Spinhoven (2001) and adapted into Turkish by Tuna and Bozo (2012) (50, 51). When the scale was analysed in terms of reliability, Cronbach's alpha coefficients of the subscales ranged between .68 and .86 in various populations. The five-point Likert-type scale (1= almost never, 2= rarely, 3= sometimes, 4= often, 5= almost always) consists of a total of 36 items. Each subscale consists of four items representing different emotion regulation strategies: self-blame, acceptance, rumination, perspective taking, positive refocusing, planning refocusing, positive reappraisal, catastrophising and blaming others. Subscale scores are obtained by summing the item scores corresponding to the relevant subscale and each subscale receives a score between 4 and 20. Higher scores on the subscales indicate a higher frequency of using the relevant emotion regulation strategy.
Measured: 3 weeks
Coping Style Scales
It is a 4-point Likert-type scale that evaluates individuals' coping styles with stress (44, 45). This scale was developed by Folkman and Lazarus (1988) and Turkish reliability and validity study was conducted by Şahin and Durak (1995). Cronbach alpha internal consistency coefficients were reported to be between 0.49-0.68 for optimistic approach, 0.62-0.80 for self-confident approach, 0.64-0.73 for helpless approach, 0.47-0.72 for submissive approach and 0.45-0.47 for social support seeking factor. SBSAS consists of 5 factors: self-confident approach, helpless approach, submissive approach, optimistic approach and seeking social support. The scale is a 5-point Likert-type self-report scale consisting of 31 items. The scale includes a metric measurement from "I Never Use" (0) to "I Always Use" (4). The scores obtained from the scale vary between 0-124.
Measured: 3 weeks
Visual Pain Scale(VPS)
The pain intensity of the pregnant women was questioned with a 10 cm visual analogue scale (VAS). In this scale, the beginning of the line indicates "no pain" (score 0) and the end of the line indicates "unbearable pain" (score 10). Pregnant women will be asked to mark the intensity of the pain they feel on the VAS. The marked point will be measured with a ruler and the results will be recorded in cm.
Measured: 3 weeks
Visual Sleep Scale(VSS)
The degree of sleep problems of the pregnant women will be evaluated using a VAS consisting of a 10 cm line. On this 10 cm line, the pregnant women will be told that the point "0" means that there is no problem with sleep and the point "10" means a very severe sleep problem and they will be asked to mark their sleep problems on this line. The marking point will be measured with the help of a ruler and the value obtained will be recorded in cm. In addition, the total amount of sleep of the pregnant women and how much sleep they wake up at night will be questioned in hours.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start5 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised controlled trial with follow-up
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur KARAKUS, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422780
- Sponsor's protocol ID
- HÜ-ERG-AK-01
- Status last verified
- Sep 2025
- First submitted
- 15 May 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women: Randomised Controlled Trial With Postpartum Follow-up
- ClinicalTrials.gov ID
- NCT06422780
- Acronym / sponsor ID
- HÜ-ERG-AK-01
- Conditions
- Pregnancy Related, Postpartum Complication
- Keywords
- pregnancy, postpartum period, occupational therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare maternal role preparation and mindfulness-centred occupational therapy trainings in pregnant women: a randomised controlled trial with postpartum follow-up.
Detailed description
Pregnancy and postpartum are a major change and crisis process for women. Women undergo hormonal, vascular, anatomical, physiological, and psychological changes for 40 weeks to meet the biochemical needs of the developing fetus, maintain homeostasis, and prepare for childbirth and lactation. These changes occurring during pregnancy are necessary to protect the health of mother and baby, as well as to prepare women for childbirth and maternity.
Psychological changes that vary from trimester to trimester, accompanied by physiological changes in pregnancy. Especially in the second and third trimester, changes in the biopsychosocial balance, affecting family and work roles, taking on new responsibilities, trying to adapt to new roles and meeting the baby increased perceived depression, anxiety and stress. These physiological and psychological symptoms during pregnancy have been to adversely affect the quality of life of pregnant women. In literature, participation in meaningful and purposeful activities, which is an important indicator of quality of life, is also believed to have an impact on occupational performance during pregnancy. During pregnancy, post-partum and postpartum, the mother is expected to adapt to the physiological and psychological changes she experiences, to be able to take care of herself and her baby, to play the role of mother and to accept her baby. Physical activity levels, sleep and quality of life during pregnancy are also likely to be affected by maternal role adaptation and participation in social life. In this context, it should be taken into account that the period of pregnancy is an important milestone for the end of childbirth and the postpartum period.
Postpartum physical problems occur in 70% of women, while 17% of women are accompanied by emotional problems.Especially in the postpartum period, emotional changes have been to occur in between 24% and 89% of women with post-partum depression (PPD), between 40% and 50% of mothers and between 9% and 30% of female with anxiety. Emotional problems can also arise as a result of a mother's physical problems, such as providing baby care, creating a safe environment for the baby, communicating with the child, learning new roles, developing family sensitivity, and dealing with problems related to the baby. Therefore, the postpartum period can become a crisis life for the family, just like pregnancy.Physical and emotional symptoms may adversely affect family, work, and social life, thereby reducing quality of life. (14,15,24). Physical and emotional symptoms have also been to negatively affect the maternal bond between the mother and the baby, the mother's sense of self, occupational balance, and occupational performance.
Occupational Theraphy is a health care profession that supports an individual's ability to sustain occupational performance through various interventions and person-centric practices, helping the individual to adapt to changes that are constantly encountered within and around him. In this context, one of the interventions used to enhance pregnancy coherence is maternal role preparation training. Maternal role preparation is an occupational training that focuses on improving motherhood competence and living a successful role-to-mother harmony when the mother becomes a mother for the first time.
One of the other interventions used in occupational therapy is a person-centric occupation therapy. In today's occupational therapy interventions, person-centric practices have always been a key element. With a person-centric approach, consultants and therapists work together to identify the nature of their occupational performance problems, the focus and need of the intervention, and the consequences of the preferred treatment.
In this context, the study was planned to study tangible behavioral changes resulting from interventions in healthy pregnant women and their impact on participation in daily life activities. Our study aims to study the effectiveness of maternal role preparation training and awareness-based occupational therapy and post-partum follow-up.
This study is important for the continuation of valuable activities and roles within pregnant women's daily routines, for the development of new strategies to make them feel better during pregnancy, and for a clinically integrated approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled trial with follow-up
| Arm | Type | Receives |
|---|---|---|
| Maternal Role Preparation Training Group | Active comparator | Other: Maternal Role Preparation TrainingPregnant women in the second trimester (14-27th week) will be included in the trainings. |
| Awareness Centred Occupational Therapy Group | Active comparator | Other: Awareness Centred Occupational Therapy GroupPregnant women in the second trimester (14-27th week) will be included in the trainings. |
| Control Group | No intervention | –Pregnant women in the second trimester (14-27th week) will be included in the trainings. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18 to 35 years of age
- Having conceived naturally
- Being between 14-27 weeks of gestation
- To be literate
- Being primiparous
Key exclusion criteria (10 listed)
- Having a risky pregnancy (gestational diabetes, eclampsia, pre-eclampsia, threatened preterm birth, premature rupture of membranes, placental anomalies etc.)
- Having a maternal physical anomaly
- Communication difficulties and mental deficiency
- Having a medical history of mental illness
- Having a foetal abnormality during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Role Preparation TrainingMaternal Role Preparation Training: Maternal Role Preparation Training (MRHE) is an occupational training programme aimed at increasing the competence of first-time mothers regarding motherhood. In this four-session programme, pregnant women will be provided with written materials, face-to-face talks and practical training covering topics related to their babies (maternal attachment, training on the sensory and developmental abilities of babies) and themselves (training on adopting a new role as a mother).The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. | Other | Maternal Role Preparation Training Group |
| Awareness Centred Occupational Therapy GroupAwareness Centred Occupational Therapy (FME); In FME, areas that affect the occupational performance of pregnant women in their daily lives will be identified and appropriate occupational therapy interventions will be applied. Awareness training on the applications will be given before starting the sessions. The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. Awareness training will be given before starting the sessions. | Other | Awareness Centred Occupational Therapy Group |
Primary outcome
Nothingham Health Profile(NHP)
Time frame: 3 weeks
The Nottingham Health Profile will be used to assess the awareness of pregnant women about their own health status. The Nottingham Health Profile assesses self-perceived health status and includes subsections on pain, emotional reactions, sleep, social isolation, physical activity and energy. These sub-sections make up the more intensively used section 1, while work life, household chores, social life, home life, sexual life, interests and holidays make up section 2. Each section is scored on a scale of 0-100. In the sections consisting of questions answered yes and no, the highest score can be 0 and the lowest score can be 100 (40,41). Turkish adaptation was performed by Küçükdeveci et al. in 1997.
8 secondary outcomes
Demographic Data Form
Time frame: 1 weeks
Occupational Balance Questionnaire(OBQ11-T)
Time frame: 3 weeks
Time Management Questionnaire(TMQ)
Time frame: 3 weeks
The Hospital Anxiety and Depression Scale(HADS)
Time frame: 3 weeks
The Cognitive Emotion Regulation Questionnaire
Time frame: 3 weeks
Coping Style Scales
Time frame: 3 weeks
Visual Pain Scale(VPS)
Time frame: 3 weeks
Visual Sleep Scale(VSS)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Role Preparation Training and Awareness Centred Occupational Therapy Group in people with Pregnancy Related and Postpartum Complication, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nothingham Health Profile(NHP) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.