Prenatal EducationNCT04838340
Effect of Hypnobirthing Training on Fear, Pain, Satisfaction and, Birth Outcomes
A study testing Standart care and Hypnobirthig training in people with Prenatal Education and Pregnancy Related, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Background and Purpose: Hypnobirthing is childbirth education model. This model aims for women to have a painless, calm and more comfortable birth. In this study is aimed to determine the effect of Hypnobirthing training on fear of childbirth, birth pain, birth satisfaction and birth outcomes. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Education, Pregnancy Related, Labor Pain
- What is being tested?
- Standart care and Hypnobirthig training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2019to 6 Mar 2021
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparas
- Ages between 18-42
- In gestational week 28-32
- Being literate in Turkish
- Pregnant with a single child
- Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)
Who cannot join
- High-risk pregnancy (on the basis of the criteria of the Ministry of Health)
- Attended other prenatal training sessions (pregnancy pilates and yoga)
- High-risk pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial
Background and Purpose: Hypnobirthing is childbirth education model. This model aims for women to have a painless, calm and more comfortable birth. In this study is aimed to determine the effect of Hypnobirthing training on fear of childbirth, birth pain, birth satisfaction and birth outcomes.
Materials and Methods: This randomized controlled experimental study was performed in Maternity Hospital (Bursa, Turkey) . The minimum required sample size to be included in the study will calculated with G* power. The simple randomization method was use in the assignment of healthy and nulliparous pregnant women at 28-32 weeks of gestation to the groups. The assignment of the participants to the experimental group or control group was carried out with a computer-aided program. The nulliparous women was divided into two groups as the control group contained women who received the hospital's usual care, and the experimental group contained women who received the hypnobirthing training intervention. The fear of birth was measured with the Wijma Birth Expectancy/Experience Scale A and B (W-DEQ); labor pain was measured with Visual Analogue Scale (VAS); birth satisfaction was measured with Short Form of Birth Satisfaction Scale (BSS-R); birth outcomes will measure with postpartum Information form. The Statistical Package for the Social Sciences program (version 25.00) was use in data analysis.
Read the detailed description
Fear of childbirth and labor pain are big problem that needs to be resolved as a priority since this situation continues by starting the vicious cycle of fear-anxiety-pain during childbirth. The persistence of the cycle increases the fear and pain related to childbirth, and thus delivery may result in emergency cesarean or elective cesarean. According to the data of Economic Development and Cooperation (OECD), the cesarean section rate in Turkey is 53.1% and so higher than the recommended rate, even Turkey has the highest rate among the OECD countries . High cesarean rates are an important problem that negatively affects maternal and infant health and increase health expenditures and costs. Therefore, the pregnant women education programs aimed at lowering the rate of cesarean section are still important in Turkey as in other countries. While the childbirth education programs for pregnant women are not widely practiced in Turkey, the Turkish Ministry of Health (TMOH) started to provide childbirth preparation courses to reduce the rate of cesarean section in recent years. In the circular issued by the TMOH in 2018, it was determined that these programs should be managed by physicians, obstetrics nurses, and midwives. Nurses are actively involved in pregnancy training programs where different methods are applied in Turkey as well as all over the world. The most common training methods applied in other countries are Lamaze Method, Bradly Method, and Hypnobirthing.
Hypnobirthing is a childbirth preparation method that aims to prepare pregnant women for delivery mentally and physically and to give birth in a less painful, conscious, and fear-free way. This method was developed based on the fear-stress-pain cycle. The persistence of this cycle exacerbates stress and pain, prolongs the birth period, and negatively affects the success, way, preference, course, and satisfaction of the birth. Thus, the birth does not proceed properly and results in an emergency or elective cesarean section. Hypnobirthing can prepare women for childbirth to eliminate all these negativities.
Hypnobirthing training can be considered as a new technique for Turkey and therefore we conducted this study to determine its effects on the pain, fear, satisfaction related to childbirth and childbirth outcomes.
- Conditions
- Prenatal Education, Pregnancy Related, Labor Pain
- Being tested
- Standart care, Hypnobirthig training
- Keywords
- Childbirth, Labor Pain, Fear of childbirth, Satisfaction, Prenatal education, Hypnobirthing
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standart careOther
This group will leave in the hospital's usual care and no intervention will be applied.
Hypnobirthig trainingBehavioural
Hypnobirthing training of the Hypnobirthing group will carry out with its partner. Hypnobirthig training will be given in small groups of 5 or 6 couples for 4 weeks and 3 hours a week. In addition, the usual care will be provided by healthcare professionals to this group.
Breathing, relaxation exercises, birth stories and birth videos will be used to reduce fears of chlildbirt women.
Deepening and endorphin massage techniques will be given for labor pain. After the endorphin massage technique will be applied individually by the researcher, it will be applied by the couples and they will ask for repeating all exercises at home.
In the last week of the training, there will be a birth rehearsal with Hynobirthing methods with the partners.
The second meeting will take place when labor begins and after labor.
| Study group | Role | What they receive |
|---|---|---|
| Standart care | Active comparator | Standart care group will leave in the hospital's usual care and no intervention will be applied. Receives: Other: Standart care |
| Hypnobirthing group | Experimental | Hypnobirthig training intervention will be applied to the Hypnobirthing group for 4 weeks and 3 hours a week and usual care will be provided by healthcare professionals. Receives: Behavioral: Hypnobirthig training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)
Distribution of the scores of pregnant women on the W-DEQ-A before the intervention to the experimental and control groups. Higher scores are worse outcome.
Measured: When the control and experimental groups were Enrollment in the study
The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)
Distribution of the women on the VAS in the first stage of labor according to the experimental and control groups. Higher scores are worse outcome.
Measured: in the process of labor (the first stage of labor: latent, active and transitional phases )
W-DEQ-B Scores (the minimum values:0, maximum:160)
Distribution of the scores of the women on the whole W-DEQ-B according to the control and experimental groups. Higher scores are worse outcome.
Measured: within eight hours after birth
The chilbirth scores of the experimental and control groups (questionnaire)
Information about the childbirth of the experimental and control groups ( childbirth position, Intervention at birth, way of delivery, duration of delivery)
Measured: within eight hours after birth
BSS-R scores of experimental and control groups (the minimum values:0, maximum:40) • Low level of satisfaction ˂13 points, • Medium satisfaction level 14-27 points, • High satisfaction level ≥28
Postpartum scores of the control and experimental groups on the BSS-R. Higher scores are better outcome.
Measured: within eight hours after birth
Secondary outcomes (1)
Women and baby interaction
The first skin to skin contact time and the first breastfeeding time of the women in the control and experimental groups
Measured: within eight hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start4 May 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prenatal EducationStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Buran, Aydin Adnan Menderes University
- Investigators
- Gonca Buran, PhD, Principal investigator, Uludag ÜniversityHilmiye Aksu, Professor, Study director, Adnan Menderes Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838340
- Sponsor's protocol ID
- 01/GB
- Status last verified
- May 2021
- First submitted
- 5 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no a plan to make individual participant data (IPD) available to other researcher on Clinical Trails.cov.
Publications
Varner CA. Comparison of the Bradley Method and HypnoBirthing Childbirth Education Classes. J Perinat Educ. 2015;24(2):128-36. doi: 10.1891/1946-6560.24.2.128.
PubMed 26957896Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
PubMed 9638601Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8.
PubMed 12694113Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
PubMed 22260727Hollins Martin CJ, Martin CR. Development and psychometric properties of the Birth Satisfaction Scale-Revised (BSS-R). Midwifery. 2014 Jun;30(6):610-9. doi: 10.1016/j.midw.2013.10.006. Epub 2013 Oct 24.
PubMed 24252712Goncu Serhatlioglu S, Karahan N, Hollins Martin CJ, Martin CR. Construct and content validity of the Turkish Birth Satisfaction Scale - Revised (T-BSS-R). J Reprod Infant Psychol. 2018 Jul;36(3):235-245. doi: 10.1080/02646838.2018.1443322. Epub 2018 Mar 19.
PubMed 29553295Sercekus P, Okumus H. Fears associated with childbirth among nulliparous women in Turkey. Midwifery. 2009 Apr;25(2):155-62. doi: 10.1016/j.midw.2007.02.005. Epub 2007 Jun 27.
PubMed 17600599Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
PubMed 26518597Phillips-Moore J. HypnoBirthing. Aust J Holist Nurs. 2005 Apr;12(1):41-2. No abstract available.
PubMed 19175270Kobayashi S, Hanada N, Matsuzaki M, Takehara K, Ota E, Sasaki H, Nagata C, Mori R. Assessment and support during early labour for improving birth outcomes. Cochrane Database Syst Rev. 2017 Apr 20;4(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.
PubMed 28426160Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2013 Jul 15;7:CD003766. doi: 10.1002/14651858.CD003766.pub5.
PubMed 23857334
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04838340
- Acronym / sponsor ID
- 01/GB
- Conditions
- Prenatal Education, Pregnancy Related, Labor Pain
- Keywords
- Childbirth, Labor Pain, Fear of childbirth, Satisfaction, Prenatal education, Hypnobirthing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 4 May 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2021 (actual)
- First posted
- 9 Apr 2021 (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.
Background and Purpose: Hypnobirthing is childbirth education model. This model aims for women to have a painless, calm and more comfortable birth. In this study is aimed to determine the effect of Hypnobirthing training on fear of childbirth, birth pain, birth satisfaction and birth outcomes.
Materials and Methods: This randomized controlled experimental study was performed in Maternity Hospital (Bursa, Turkey) . The minimum required sample size to be included in the study will calculated with G* power. The simple randomization method was use in the assignment of healthy and nulliparous pregnant women at 28-32 weeks of gestation to the groups. The assignment of the participants to the experimental group or control group was carried out with a computer-aided program. The nulliparous women was divided into two groups as the control group contained women who received the hospital's usual care, and the experimental group contained women who received the hypnobirthing training intervention. The fear of birth was measured with the Wijma Birth Expectancy/Experience Scale A and B (W-DEQ); labor pain was measured with Visual Analogue Scale (VAS); birth satisfaction was measured with Short Form of Birth Satisfaction Scale (BSS-R); birth outcomes will measure with postpartum Information form. The Statistical Package for the Social Sciences program (version 25.00) was use in data analysis.
Detailed description
Fear of childbirth and labor pain are big problem that needs to be resolved as a priority since this situation continues by starting the vicious cycle of fear-anxiety-pain during childbirth. The persistence of the cycle increases the fear and pain related to childbirth, and thus delivery may result in emergency cesarean or elective cesarean. According to the data of Economic Development and Cooperation (OECD), the cesarean section rate in Turkey is 53.1% and so higher than the recommended rate, even Turkey has the highest rate among the OECD countries . High cesarean rates are an important problem that negatively affects maternal and infant health and increase health expenditures and costs. Therefore, the pregnant women education programs aimed at lowering the rate of cesarean section are still important in Turkey as in other countries. While the childbirth education programs for pregnant women are not widely practiced in Turkey, the Turkish Ministry of Health (TMOH) started to provide childbirth preparation courses to reduce the rate of cesarean section in recent years. In the circular issued by the TMOH in 2018, it was determined that these programs should be managed by physicians, obstetrics nurses, and midwives. Nurses are actively involved in pregnancy training programs where different methods are applied in Turkey as well as all over the world. The most common training methods applied in other countries are Lamaze Method, Bradly Method, and Hypnobirthing.
Hypnobirthing is a childbirth preparation method that aims to prepare pregnant women for delivery mentally and physically and to give birth in a less painful, conscious, and fear-free way. This method was developed based on the fear-stress-pain cycle. The persistence of this cycle exacerbates stress and pain, prolongs the birth period, and negatively affects the success, way, preference, course, and satisfaction of the birth. Thus, the birth does not proceed properly and results in an emergency or elective cesarean section. Hypnobirthing can prepare women for childbirth to eliminate all these negativities.
Hypnobirthing training can be considered as a new technique for Turkey and therefore we conducted this study to determine its effects on the pain, fear, satisfaction related to childbirth and childbirth outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standart care | Active comparator | Other: Standart careStandart care group will leave in the hospital's usual care and no intervention will be applied. |
| Hypnobirthing group | Experimental | Behavioral: Hypnobirthig trainingHypnobirthig training intervention will be applied to the Hypnobirthing group for 4 weeks and 3 hours a week and usual care will be provided by healthcare professionals. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparas
- Ages between 18-42
- In gestational week 28-32
- Being literate in Turkish
- Pregnant with a single child
Key exclusion criteria (3 listed)
- High-risk pregnancy (on the basis of the criteria of the Ministry of Health)
- Attended other prenatal training sessions (pregnancy pilates and yoga)
- High-risk 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 |
|---|---|---|
| Standart careThis group will leave in the hospital's usual care and no intervention will be applied. | Other | Standart care |
| Hypnobirthig trainingHypnobirthing training of the Hypnobirthing group will carry out with its partner. Hypnobirthig training will be given in small groups of 5 or 6 couples for 4 weeks and 3 hours a week. In addition, the usual care will be provided by healthcare professionals to this group. Breathing, relaxation exercises, birth stories and birth videos will be used to reduce fears of chlildbirt women. Deepening and endorphin massage techniques will be given for labor pain. After the endorphin massage technique will be applied individually by the researcher, it will be applied by the couples and they will ask for repeating all exercises at home. In the last week of the training, there will be a birth rehearsal with Hynobirthing methods with the partners. The second meeting will take place when labor begins and after labor. | Behavioural | Hypnobirthing group |
Primary outcome
Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)
Time frame: When the control and experimental groups were Enrollment in the study
Distribution of the scores of pregnant women on the W-DEQ-A before the intervention to the experimental and control groups. Higher scores are worse outcome.
The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)
Time frame: in the process of labor (the first stage of labor: latent, active and transitional phases )
Distribution of the women on the VAS in the first stage of labor according to the experimental and control groups. Higher scores are worse outcome.
W-DEQ-B Scores (the minimum values:0, maximum:160)
Time frame: within eight hours after birth
Distribution of the scores of the women on the whole W-DEQ-B according to the control and experimental groups. Higher scores are worse outcome.
The chilbirth scores of the experimental and control groups (questionnaire)
Time frame: within eight hours after birth
Information about the childbirth of the experimental and control groups ( childbirth position, Intervention at birth, way of delivery, duration of delivery)
BSS-R scores of experimental and control groups (the minimum values:0, maximum:40) • Low level of satisfaction ˂13 points, • Medium satisfaction level 14-27 points, • High satisfaction level ≥28
Time frame: within eight hours after birth
Postpartum scores of the control and experimental groups on the BSS-R. Higher scores are better outcome.
1 secondary outcome
Women and baby interaction
Time frame: within eight hours after birth
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 6 May 2021.
- Background: PubMed 26957896Varner CA. Comparison of the Bradley Method and HypnoBirthing Childbirth Education Classes. J Perinat Educ. 2015;24(2):128-36. doi: 10.1891/1946-6560.24.2.128.
- Background: PubMed 9638601Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
- Background: PubMed 12694113Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8.
- Background: PubMed 22260727Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
- Background: PubMed 24252712Hollins Martin CJ, Martin CR. Development and psychometric properties of the Birth Satisfaction Scale-Revised (BSS-R). Midwifery. 2014 Jun;30(6):610-9. doi: 10.1016/j.midw.2013.10.006. Epub 2013 Oct 24.
- Background: PubMed 29553295Goncu Serhatlioglu S, Karahan N, Hollins Martin CJ, Martin CR. Construct and content validity of the Turkish Birth Satisfaction Scale - Revised (T-BSS-R). J Reprod Infant Psychol. 2018 Jul;36(3):235-245. doi: 10.1080/02646838.2018.1443322. Epub 2018 Mar 19.
- Background: PubMed 17600599Sercekus P, Okumus H. Fears associated with childbirth among nulliparous women in Turkey. Midwifery. 2009 Apr;25(2):155-62. doi: 10.1016/j.midw.2007.02.005. Epub 2007 Jun 27.
- Results publication: PubMed 26518597Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
- Results publication: PubMed 19175270Phillips-Moore J. HypnoBirthing. Aust J Holist Nurs. 2005 Apr;12(1):41-2. No abstract available.
- Results publication: PubMed 28426160Kobayashi S, Hanada N, Matsuzaki M, Takehara K, Ota E, Sasaki H, Nagata C, Mori R. Assessment and support during early labour for improving birth outcomes. Cochrane Database Syst Rev. 2017 Apr 20;4(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.
- Results publication: PubMed 23857334Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2013 Jul 15;7:CD003766. doi: 10.1002/14651858.CD003766.pub5.
- Individual participant dataSharing planned: No. there is no a plan to make individual participant data (IPD) available to other researcher on Clinical Trails.cov.
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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.
Gonca Buran, PhD principal investigator
Uludag Üniversity
Hilmiye Aksu, Professor study director
Adnan Menderes Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standart care and Hypnobirthig training in people with Prenatal Education and Pregnancy Related, run by Aydin Adnan Menderes 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 6 inclusion and 3 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 6 May 2021. 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?
Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165) (time frame: When the control and experimental groups were Enrollment in the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04838340, which also lists 11 linked publications.
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 6 May 2021.