Primipara PregnantbreathingNCT06520930
The Effect of Breathing Exercises on Comfort Level in Primiparous Pregnant Women
A study testing breathing exercise therapy in people with Primipara Pregnant, run by Sibel Kucuk at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy is a special period in which some changes occur in bio-psycho-social areas and adaptation to these changes is achieved (Üzar and Erkan; 2019). While this special period creates happiness and peace in some women, it can cause emotional and relational changes in some women, create anxiety and anxiety, and… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primipara Pregnant
- What is being tested?
- breathing exercise therapy
- 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
- 19 Mar 2024to 15 Jul 2024
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study, Those aged 19 and over, non-smoker Without a risky pregnancy diagnosis (without obstetric complications, psychiatric diagnosis, ear, nose or throat problems and systemic disease) Literate and without communication difficulties 2nd trimester primiparous pregnant women who are 21st week of pregnancy and later
Who cannot join
- They want to withdraw from the research at any point during the research. Those who accept face-to-face application and then give up or do not continue the application, Not doing daily breathing exercises, Couldn\'t be reached by the researcher even though he called at most three times a day, Changing hospital, Women who fill out the research data collection forms incompletely will be excluded from the sample.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Structured Supportive Approach Based on Kolcaba Comfort Theory Applied to Primiparous Pregnant Women on the Comfort Level in the Last Trimester
Pregnancy is a special period in which some changes occur in bio-psycho-social areas and adaptation to these changes is achieved (Üzar and Erkan; 2019). While this special period creates happiness and peace in some women, it can cause emotional and relational changes in some women, create anxiety and anxiety, and negatively affect their comfort level (Al-Mutawtah et al., 2023; Yar and Yılmaz, 2021). In order to reduce the effects of complaints experienced during pregnancy and ensure adaptation, nurses who provide holistic, innovative, effective and supportive care, determine the comfort needs of the individual and the family, and improve their comfort levels by planning and applying interventions specific to the areas needed.
It increases. (Arslankılıç and Göl, 2020; Kolcaba1991). In this context, breathing exercises, which are defined as an invisible spirit that provides the connection between body, mind and soul, gives life to its owner, has an important place in order to increase the comfort level and ensure adaptation to the pregnancy process (Kartal, 2018). Because breathing exercises stimulate the parasympathetic nervous system, increase blood oxygenation and, as a result, trigger the secretion of endorphins. The increased release of endorphins reduces the heart rate, resulting in a feeling of calm. In addition, endorphin suppresses the sympathetic nervous system and reduces the release of cortisol, the stress hormone, thus keeping psychotic emotions under control (Issac, et al., 2023).Thus, the complaints that occur during pregnancy can be minimized with correct and effective breathing techniques and the comfort level can be increased. As a result of literature reviews; Regular breathing exercises increase lung volume, increase the endurance and efficiency of the diaphragm muscle, reduce dyspnea, provide easier breathing, and help eliminate bronchial secretions (Özulus, 2018; Tucker and Jenkins 1996). It has been found that it is effective in reducing hypertension, fatigue and anxiety, and that a 30-session intervention lasting 5 minutes per day for women who have given birth prematurely significantly reduces anxiety (Ölçer and Oskay; 2015; Chang et al., 2009). For this reason, the concept of comfort should be evaluated multidimensionally during pregnancy and holistic nursing interventions should be implemented to increase the comfort level.
In this study, it is envisaged that breathing exercise practices will increase the general comfort level of primiparous women, such as adaptation to pregnancy, increase in sleep quality, decrease in pain, decrease in anxiety levels, improvement in vital signs and conscious management of third trimester changes. At the same time, these research findings will constitute an important data source in research on the general comfort level effectiveness of breathing exercises to be performed on primiparous pregnant women from the 2nd trimester onwards in the 3rd trimester. Because, no randomized controlled study has been conducted in Turkey regarding the effect of breathing exercise on the general comfort level of last trimester pregnant women.
Read the detailed description
The population of the research consists of primiparous women who applied to the Private Metrolife Hospital Obstetrics and Gynecology outpatient clinic. The sample size of the study was determined using post hoc power analysis G-Power 3.1.9.4 program. In the power analysis conducted for the research, it was determined that a total of 72 primiparous women, including at least 36 people in both groups, were included in the study in order to reach a 95% confidence interval, an effect size of 0.6, an α-type error estimate of 0.05 and 80% power in the experimental and control groups with the pretest-posttest. It was determined that there was a need for inclusion. In view of the possibility that primiparous pregnant women who will participate in the study may withdraw from the study for various reasons, the total number of primiparous pregnant women was determined as 80, 40 for the control group and 40 for the experimental group. The research was completed with 40 primiparous pregnant women in the intervention group and 40 primiparous pregnant women in the control group, according to the CONSORT flow chart.
The breathing exercises to be applied were taught face to face to each pregnant woman by the researcher who has a \"Breathing Therapy\" certificate. The taught practice was then repeated by the pregnant woman and the researcher together. In the next step, pregnant women were asked to perform the application themselves. In this way, it was determined whether individual breathing exercise practices were performed correctly and effectively. After the one-on-one training was completed, the pregnant women were divided into groups of maximum six people and breathing exercise exercises were performed 7 days a week, once a day and once a week face-to-face for 8 weeks. Breathing exercises were administered face to face to a maximum of two groups per day, and each session lasted approximately 45 minutes. In addition, for 8 weeks, a short reminder message was sent to pregnant women every morning (between 10:00-11:00) to prevent them from disrupting their daily breathing exercise practices, and they were called in the evening (between 17:00-18:00) to check whether they had performed the application correctly or not. It was checked whether they were experiencing any problems.
Data collection tools; Introductory Information Form: This form was prepared by the researcher by scanning the relevant literature; Socio-demographic characteristics of primiparous pregnant women (age, age at marriage, duration of marriage, education level, profession, income level, social security status, place of residence, family structure), obstetric characteristics (gestational age, planned pregnancy, problems experienced during pregnancy, any relaxing practice) and pulse, respiratory rate and saturation values were checked.
General Comfort Scale (GAS) was used. The intervention group had data collection tools filled out before and after therapy.
Statistical significance level will be accepted as p\<0.05.
- Conditions
- Primipara Pregnant
- Being tested
- breathing exercise therapy
- Keywords
- primipara pregnant, comfort, breathing therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercise therapyBehavioural
Description: The breathing exercises to be applied were taught to each pregnant woman face to face with one-on-one training. The taught practice was then repeated by the pregnant woman and the researcher together. In the next step, pregnant women were asked to perform the application themselves. In this way, it was determined whether individual breathing exercise practices were performed correctly and effectively. After the one-on-one training was completed, the pregnant women were divided into groups of maximum six people and breathing exercise exercises were performed 7 days a week, once a day and once a week face-to-face for 8 weeks. Each session lasted approximately 45 minutes. For 8 weeks, a short reminder message was sent to pregnant women every morning to ensure that they did not interrupt their daily breathing exercise practices, and they were called in the evening to check whether they had performed the application correctly and whether they had any problems.
| Study group | Role | What they receive |
|---|---|---|
| Arms | No intervention | First Stage: As a pre-test, pulse, respiratory rate and saturation values will be checked, Descriptive Questionnaire and General Comfort Scale (GAS) will be applied to primiparous pregnant women in the control group. Second Stage: As the final test, the heart rate, respiratory rate, blood pressure and saturation values will be checked again at the end of the 8th session for primiparous pregnant women, and the Descriptive Questionnaire and General Comfort Scale (GAS) will be applied. |
| Intervention Group | Experimental | As a pre-test, pulse, respiratory rate, blood pressure and saturation values will be checked, Descriptive Questionnaire and General Comfort Scale (GAS) will be applied to the primiparous pregnant women in the experimental groups. Breathing therapy exercises based on Kolcaba's comfort theory were designed as face-to-face training by the researcher himself, who received breathing therapy training for primiparous pregnant women once a week, for a total of 8 sessions. 6 pieces will be created within the session. Each session lasts approximately 45-60 minutes. As the final test, pulse, respiratory rates, blood pressure and saturation values will be checked again at the end of the 8th session/week to determine the change in primiparous pregnant women, and the Descriptive Questionnaire and General Comfort Scale (GAS) will be applied. Receives: Behavioral: breathing exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
socio-demographic characteristics of primiparous pregnant women (age, age at marriage, duration of marriage, education level, profession, income level, social security status, place of residence, family structure), obstetric characteristics (gestational age, planned pregnancy, pregnancy It will be used to obtain information about the problems experienced, any relaxing practice during pregnancy) and pulse, respiratory rate and saturation values.
Measured: Pregnant women in the experimental and control groups will be evaluated with the start of the study
Secondary outcomes (1)
General Comfort Scale (GAS)
The general comfort scale was developed by Katherine Kolcaba in 1992. The Turkish validity and reliability study of the scale was conducted by Kuğuoğlu and Karabacak (2008). The scale is a four-point Likert type and consists of a total of 48 items. Comfort levels of the scale; relief (16 items), relaxation (17 items) and overcoming problems (15 items). The response patterns of the scale, which consists of positive and negative items, are given in a mixed manner. Accordingly, in positive items, a high score (4) indicates high comfort and a low score (1) indicates low comfort. In the evaluation of the scale, the negative scores obtained (5, 6, 8, 12, 13, 14, 18, 19, 20, 21, 22, 24, 2526, 28, 32, 34, 35, 39, 40, 41, 42, 45, 48) are reverse coded and summed with positive items. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. Low comfort is expressed with one point, high comfort with four points. In the validity and reliability study, t
Measured: It will be filled out before starting the study for the experimental and control groups, and will be filled in again to compare both groups in the 3rd trimester after the training is completed for the experimental group in the 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start19 Mar 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primipara PregnantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Kucuk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel Kucuk, Harran University
- Investigators
- SİBEL KÜÇÜK, Lecturer, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520930
- Sponsor's protocol ID
- HRN-SK-44
- Acronym
- breathing
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Mutawtah M, Campbell E, Kubis HP, Erjavec M. Women's experiences of social support during pregnancy: a qualitative systematic review. BMC Pregnancy Childbirth. 2023 Nov 10;23(1):782. doi: 10.1186/s12884-023-06089-0.
PubMed 37950165Kucuk S, Sevil U, Sak S. Effects of Kolcaba's comfort theory-based breathing awareness intervention initiated in the second trimester on third-trimester comfort in primiparous women: a randomised controlled trial. Midwifery. 2026 Aug;159:104831. doi: 10.1016/j.midw.2026.104831. Epub 2026 May 1.
PubMed 42102778
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Structured Supportive Approach Based on Kolcaba Comfort Theory Applied to Primiparous Pregnant Women on the Comfort Level in the Last Trimester
- ClinicalTrials.gov ID
- NCT06520930
- Acronym / sponsor ID
- breathing / HRN-SK-44
- Conditions
- Primipara Pregnant
- Keywords
- primipara pregnant, comfort, breathing therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sibel KucukUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 25 Jul 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.
Pregnancy is a special period in which some changes occur in bio-psycho-social areas and adaptation to these changes is achieved (Üzar and Erkan; 2019). While this special period creates happiness and peace in some women, it can cause emotional and relational changes in some women, create anxiety and anxiety, and negatively affect their comfort level (Al-Mutawtah et al., 2023; Yar and Yılmaz, 2021). In order to reduce the effects of complaints experienced during pregnancy and ensure adaptation, nurses who provide holistic, innovative, effective and supportive care, determine the comfort needs of the individual and the family, and improve their comfort levels by planning and applying interventions specific to the areas needed.
It increases. (Arslankılıç and Göl, 2020; Kolcaba1991). In this context, breathing exercises, which are defined as an invisible spirit that provides the connection between body, mind and soul, gives life to its owner, has an important place in order to increase the comfort level and ensure adaptation to the pregnancy process (Kartal, 2018). Because breathing exercises stimulate the parasympathetic nervous system, increase blood oxygenation and, as a result, trigger the secretion of endorphins. The increased release of endorphins reduces the heart rate, resulting in a feeling of calm. In addition, endorphin suppresses the sympathetic nervous system and reduces the release of cortisol, the stress hormone, thus keeping psychotic emotions under control (Issac, et al., 2023).Thus, the complaints that occur during pregnancy can be minimized with correct and effective breathing techniques and the comfort level can be increased. As a result of literature reviews; Regular breathing exercises increase lung volume, increase the endurance and efficiency of the diaphragm muscle, reduce dyspnea, provide easier breathing, and help eliminate bronchial secretions (Özulus, 2018; Tucker and Jenkins 1996). It has been found that it is effective in reducing hypertension, fatigue and anxiety, and that a 30-session intervention lasting 5 minutes per day for women who have given birth prematurely significantly reduces anxiety (Ölçer and Oskay; 2015; Chang et al., 2009). For this reason, the concept of comfort should be evaluated multidimensionally during pregnancy and holistic nursing interventions should be implemented to increase the comfort level.
In this study, it is envisaged that breathing exercise practices will increase the general comfort level of primiparous women, such as adaptation to pregnancy, increase in sleep quality, decrease in pain, decrease in anxiety levels, improvement in vital signs and conscious management of third trimester changes. At the same time, these research findings will constitute an important data source in research on the general comfort level effectiveness of breathing exercises to be performed on primiparous pregnant women from the 2nd trimester onwards in the 3rd trimester. Because, no randomized controlled study has been conducted in Turkey regarding the effect of breathing exercise on the general comfort level of last trimester pregnant women.
Detailed description
The population of the research consists of primiparous women who applied to the Private Metrolife Hospital Obstetrics and Gynecology outpatient clinic. The sample size of the study was determined using post hoc power analysis G-Power 3.1.9.4 program. In the power analysis conducted for the research, it was determined that a total of 72 primiparous women, including at least 36 people in both groups, were included in the study in order to reach a 95% confidence interval, an effect size of 0.6, an α-type error estimate of 0.05 and 80% power in the experimental and control groups with the pretest-posttest. It was determined that there was a need for inclusion. In view of the possibility that primiparous pregnant women who will participate in the study may withdraw from the study for various reasons, the total number of primiparous pregnant women was determined as 80, 40 for the control group and 40 for the experimental group. The research was completed with 40 primiparous pregnant women in the intervention group and 40 primiparous pregnant women in the control group, according to the CONSORT flow chart.
The breathing exercises to be applied were taught face to face to each pregnant woman by the researcher who has a \&#34;Breathing Therapy\&#34; certificate. The taught practice was then repeated by the pregnant woman and the researcher together. In the next step, pregnant women were asked to perform the application themselves. In this way, it was determined whether individual breathing exercise practices were performed correctly and effectively. After the one-on-one training was completed, the pregnant women were divided into groups of maximum six people and breathing exercise exercises were performed 7 days a week, once a day and once a week face-to-face for 8 weeks. Breathing exercises were administered face to face to a maximum of two groups per day, and each session lasted approximately 45 minutes. In addition, for 8 weeks, a short reminder message was sent to pregnant women every morning (between 10:00-11:00) to prevent them from disrupting their daily breathing exercise practices, and they were called in the evening (between 17:00-18:00) to check whether they had performed the application correctly or not. It was checked whether they were experiencing any problems.
Data collection tools; Introductory Information Form: This form was prepared by the researcher by scanning the relevant literature; Socio-demographic characteristics of primiparous pregnant women (age, age at marriage, duration of marriage, education level, profession, income level, social security status, place of residence, family structure), obstetric characteristics (gestational age, planned pregnancy, problems experienced during pregnancy, any relaxing practice) and pulse, respiratory rate and saturation values were checked.
General Comfort Scale (GAS) was used. The intervention group had data collection tools filled out before and after therapy.
Statistical significance level will be accepted as p\<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment two groups
| Arm | Type | Receives |
|---|---|---|
| Arms | No intervention | –First Stage: As a pre-test, pulse, respiratory rate and saturation values will be checked, Descriptive Questionnaire and General Comfort Scale (GAS) will be applied to primiparous pregnant women in the control group. Second Stage: As the final test, the heart rate, respiratory rate, blood pressure and saturation values will be checked again at the end of the 8th session for primiparous pregnant women, and the Descriptive Questionnaire and General Comfort Scale (GAS) will be applied. |
| Intervention Group | Experimental | Behavioral: breathing exercise therapyAs a pre-test, pulse, respiratory rate, blood pressure and saturation values will be checked, Descriptive Questionnaire and General Comfort Scale (GAS) will be applied to the primiparous pregnant women in the experimental groups. Breathing therapy exercises based on Kolcaba's comfort theory were designed as face-to-face training by the researcher himself, who received breathing therapy training for primiparous pregnant women once a week, for a total of 8 sessions. 6 pieces will be created within the session. Each session lasts approximately 45-60 minutes. As the final test, pulse, respiratory rates, blood pressure and saturation values will be checked again at the end of the 8th session/week to determine the change in primiparous pregnant women, and the Descriptive Questionnaire and General Comfort Scale (GAS) will be applied. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer to participate in the study, Those aged 19 and over, non-smoker Without a risky pregnancy diagnosis (without obstetric complications, psychiatric diagnosis, ear, nose or throat problems and systemic disease) Literate and without communication difficulties 2nd trimester primiparous pregnant women who are 21st week of pregnancy and later
Key exclusion criteria (2 listed)
- They want to withdraw from the research at any point during the research. Those who accept face-to-face application and then give up or do not continue the application, Not doing daily breathing exercises, Couldn\'t be reached by the researcher even though he called at most three times a day, Changing hospital, Women who fill out the research data collection forms incompletely will be excluded from the sample.
- -
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 |
|---|---|---|
| breathing exercise therapyDescription: The breathing exercises to be applied were taught to each pregnant woman face to face with one-on-one training. The taught practice was then repeated by the pregnant woman and the researcher together. In the next step, pregnant women were asked to perform the application themselves. In this way, it was determined whether individual breathing exercise practices were performed correctly and effectively. After the one-on-one training was completed, the pregnant women were divided into groups of maximum six people and breathing exercise exercises were performed 7 days a week, once a day and once a week face-to-face for 8 weeks. Each session lasted approximately 45 minutes. For 8 weeks, a short reminder message was sent to pregnant women every morning to ensure that they did not interrupt their daily breathing exercise practices, and they were called in the evening to check whether they had performed the application correctly and whether they had any problems. | Behavioural | Intervention Group |
Primary outcome
Introductory Information Form
Time frame: Pregnant women in the experimental and control groups will be evaluated with the start of the study
socio-demographic characteristics of primiparous pregnant women (age, age at marriage, duration of marriage, education level, profession, income level, social security status, place of residence, family structure), obstetric characteristics (gestational age, planned pregnancy, pregnancy It will be used to obtain information about the problems experienced, any relaxing practice during pregnancy) and pulse, respiratory rate and saturation values.
1 secondary outcome
General Comfort Scale (GAS)
Time frame: It will be filled out before starting the study for the experimental and control groups, and will be filled in again to compare both groups in the 3rd trimester after the training is completed for the experimental group in the 8th week.
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 25 Jul 2024.
- Results publication: PubMed 37950165Al-Mutawtah M, Campbell E, Kubis HP, Erjavec M. Women's experiences of social support during pregnancy: a qualitative systematic review. BMC Pregnancy Childbirth. 2023 Nov 10;23(1):782. doi: 10.1186/s12884-023-06089-0.
- Derived from this study: PubMed 42102778Kucuk S, Sevil U, Sak S. Effects of Kolcaba's comfort theory-based breathing awareness intervention initiated in the second trimester on third-trimester comfort in primiparous women: a randomised controlled trial. Midwifery. 2026 Aug;159:104831. doi: 10.1016/j.midw.2026.104831. Epub 2026 May 1.
- 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.
SİBEL KÜÇÜK, Lecturer principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercise therapy in people with Primipara Pregnant, run by Sibel Kucuk 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 1 inclusion and 2 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 25 Jul 2024. 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?
Introductory Information Form (time frame: Pregnant women in the experimental and control groups will be evaluated with the start of the study). 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 NCT06520930, which also lists 2 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 25 Jul 2024.