Preterm InfantsNCT06201962
Effect of Massage and Foot Reflexology on Newborns' Sleep
A study testing Massage and Foot Reflexology in people with Preterm Infants and Sleep, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Newborns undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life for various reasons. Read more about this study
- Who is it for?
- Ages 30 to 37 weeks
- Conditions the study is for
- Preterm Infants, Sleep
- What is being tested?
- Massage and Foot Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 2 Aug 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 30 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those born between 30-37 weeks of gestation and hospitalized in the Neonatal Intensive Care Unit
- Those who have a healthy skin structure (no acne, urticaria, eczema or any allergic problems)
- Birth weight of 1500 g and above,
- Do not have a medical condition (surgical intervention, mass, umbilical catheter, etc.) that contraindicates area massage.
- Those whose vital signs are stable
Who cannot join
- Those whose vital signs are stable
- Those with foot anomalies or those who underwent outpatient surgery
- Those dependent on high-frequency mechanical ventilation
- Those receiving sedative treatment
- Those with hyperbilirubinemia
- Babies with hypoglycemia or hyperglycemia
- Those with genetic and congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: Newborns undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life for various reasons. Leaving the warm, dark, quiet, calm, fluid-filled mother's womb of newborns whose systems are not yet mature and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake pattern required for growth-development and neurodevelopment. It is intensive for the development of newborns' neurosensory systems. They have sleep requirements. It is known that the brain activity of newborns during the intrauterine period is similar to REM (Rapid Eye Movement) sleep activity, they sleep more than adults, and they spend most of their sleep in the REM sleep period. For this reason, our research will be conducted to examine the effects of massage and foot reflexology applied to preterm newborns on sleep.
Design and Methods: This randomized experimental study was carried out on 108 preterm newborns with gestational weeks between 30-37, hospitalized in the neonatal intensive care unit of a city hospital. The researcher was applied massage (n:36) and foot reflexology (n:36) to the newborns for 15 minutes, twice a day for 2 days. No intervention other than routine clinical practices was applied to the control group (n:36). The 24-hour sleep of the newborns included in the study was monitored with a sleep-wakefulness measuring device before the application and on the day the naps end, and was recorded in the newborn follow-up form. Statistical analysis was performed using percentages, means, median, variance and Kruskal Wallis, Wilcoxon tests test.
Read the detailed description
Sleep is very important for human life and developmentally involves both physiological and mental processes. Sleep is considered not only as a state of rest, but also as a state of intense brain development in which neurotransmitters specific to each sleep stage affect brain maturation . Newborns sleep an average of 16-20 hours a day, spending most of their sleep in the REM (Rapid Eye Movement Phase) sleep period. For this reason, sleep quality in the neonatal period directly affects healthy growth and development. Newborns, who leave the warm, dark, quiet, calm, amniotic fluid-filled mother's womb at birth, undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life due to various reasons .
Babies who leave the intrauterine period early are admitted to technologically equipped neonatal intensive care units. In the neonatal intensive care unit, they are exposed to many stressful stimuli and environmental factors. Premature babies are exposed to painful invasive procedures in the neonatal intensive care unit, negative environmental conditions such as frequent feeding, exposure to high-frequency sounds and constant light negatively affect their sleep-wake cycles.
There are studies in the literature to determine the sleep and wakefulness status of premature babies and the factors affecting them. There are studies examining massage, position and music practices applied to preterm babies. It was observed that the number of babies sleeping was higher in the measurements made after massage therapy in premature babies who received massage and premature babies who did not. Additionally, in his systematic review of massage practice; It has been revealed that it increases mother-baby interaction and positively affects sleep conditions by reducing stress levels and crying .
Today, the use of complementary and alternative medicine treatments is increasing in healthcare systems all over the world. Nurses can use these ways, along with regular treatments, to improve health. In this context, foot reflexology, one of the six most commonly used treatments in complementary medicine, is effective not only in the treatment of diseases but also in protecting health. Reflexology is defined as the science that stimulates the ends of sensory nerves connected to receptors and points related to the internal organs of the body using different degrees of pressure, such as massage and touch. By applying the compression technique to the reflection point of each organ using reflexology, the blockage in the energy flow path is removed and as a result, the energy flows in the movement channels. It has been stated that foot reflexology can improve the physiological index and reduce O2 saturation, heart rate, and inspire relaxation in newborns . There are studies examining the effects of invasive procedures on pain, comfort and physiological parameters .
Developing individualized supportive interventions that ensure deep sleep and wakefulness is important for the quality of care provided to preterm infants. For this reason, it is important to reduce the negativities caused by neonatal intensive care units, improve care, reduce pain caused by invasive procedures and the environment, and ensure the sleep quality and order of premature babies.
There are studies in the literature about the effects of massage and foot reflexology on pain, comfort and vital signs in preterm babies, but no study has been found comparing these methods and examining their effects on sleep. In the literature review, while there are studies in which parents subjectively evaluate children's sleep, no other studies were found in which premature babies' sleep is measured objectively. Therefore, it will be carried out to examine the effects of massage and foot reflexology applied to premature babies on sleep.
- Conditions
- Preterm Infants, Sleep
- Being tested
- Massage, Foot Reflexology, Control
- Keywords
- Preterm Infants, Sleep Wake Cycle, Massage, Foot Reflexology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Massage applications will be performed for 15 minutes every morning and evening for two days.
Foot ReflexologyOther
In the reflexology group, the researcher will hold the baby's foot with his left hand and gently massage each foot with the thumb of his right hand for 15 minutes.
ControlOther
Newborns will receive routine medical treatment and nursing care and will not undergo any procedures.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information will be given about the massage to be performed on the newborn. Before applying massage to premature babies, their 24-hour sleep duration will be evaluated with an actigraphy device. Starting from the face with gentle touches, massage will be applied to the baby's forehead, around the eyes and cheeks with 2 fingers, without pressing too much. Then, the chest area will be massaged with circular movements from right to left, and then the upper and lower extremities will be massaged. Finally, the massage will be completed by turning the baby face down and applying gentle pressure to the back area. Massage applications will be performed for 15 minutes every morning and evening for two days. On the morning of the second day, an actigraphy device will be attached to the premature babies' ankles and their 24-hour sleep will be re-evaluated. Receives: Other: Massage |
| Foot Reflexology | Experimental | Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information will be given about the foot reflexology to be performed on the newborn. In addition to daily routine nursing care and monitoring for premature babies, before applying foot reflexology, the actigraphy device will be attached to the babies' ankles and their 24-hour sleep duration will be evaluated. In the reflexology group, the researcher will hold the baby's foot with his left hand and gently massage each foot with the thumb of his right hand for 15 minutes. Foot reflexology will be performed for 15 minutes every morning and evening for two days. On the morning of the second day, an actigraphy device will be attached to the premature babies' ankles and their 24-hour sleep will be re-evaluated. Receives: Other: Foot Reflexology |
| Control | Experimental | Newborns will receive routine medical treatment and nursing care and will not undergo any procedures. Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information about the study will be given. Premature babies will have their 24-hour sleep recorded with actigraphy 1 day in advance. Then, the nursing care that premature babies receive in their daily routine will be given for two days. On the morning of the second day, an actigraphy device will be attached to the left foot of the premature babies and their 24-hour sleep on the second day will be recorded. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep
The researcher will monitor the newborn babies' sleep times with a sleep-wake measurement device for 24 hours and record them in the Newborn Follow-up Form.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Sep 2023
- Primary completion15 Feb 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies 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
- This study used a randomized controlled trial. A parallel trial design was used describing two different experimental groups (Massage and Foot Reflexology) and a control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Belpınar, Bozok University
- Investigators
- Ayşe Belpınar, Phd, Principal investigator, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201962
- Sponsor's protocol ID
- ABozokU
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Groot ER, Knoop MS, van den Hoogen A, Wang X, Long X, Pillen S, Benders M, Dudink J. The value of cardiorespiratory parameters for sleep state classification in preterm infants: A systematic review. Sleep Med Rev. 2021 Aug;58:101462. doi: 10.1016/j.smrv.2021.101462. Epub 2021 Mar 14.
PubMed 33826975Sentner T, Wang X, de Groot ER, van Schaijk L, Tataranno ML, Vijlbrief DC, Benders MJNL, Bartels R, Dudink J. The Sleep Well Baby project: an automated real-time sleep-wake state prediction algorithm in preterm infants. Sleep. 2022 Oct 10;45(10):zsac143. doi: 10.1093/sleep/zsac143.
PubMed 35749799Firmino C, Rodrigues M, Franco S, Ferreira J, Simoes AR, Castro C, Fernandes JB. Nursing Interventions That Promote Sleep in Preterm Newborns in the Neonatal Intensive Care Units: An Integrative Review. Int J Environ Res Public Health. 2022 Sep 2;19(17):10953. doi: 10.3390/ijerph191710953.
PubMed 36078666Park J. Sleep Promotion for Preterm Infants in the NICU. Nurs Womens Health. 2020 Feb;24(1):24-35. doi: 10.1016/j.nwh.2019.11.004. Epub 2020 Feb 19.
PubMed 32083554Uchitel J, Vanhatalo S, Austin T. Early development of sleep and brain functional connectivity in term-born and preterm infants. Pediatr Res. 2022 Mar;91(4):771-786. doi: 10.1038/s41390-021-01497-4. Epub 2021 Apr 15.
PubMed 33859364Jazayeri Z, Sajadi M, Dalvand H, Zolfaghari M. Comparison of the effect of foot reflexology and body massage on physiological indicators and bilirubin levels in neonates under phototherapy. Complement Ther Med. 2021 Jun;59:102684. doi: 10.1016/j.ctim.2021.102684. Epub 2021 Feb 17.
PubMed 33609634Baniasadi H, Hosseini SS, Abdollahyar A, Sheikhbardsiri H. Effect of massage on behavioural responses of preterm infants in an educational hospital in Iran. J Reprod Infant Psychol. 2019 Jul;37(3):302-310. doi: 10.1080/02646838.2019.1578866. Epub 2019 Feb 21.
PubMed 30786750
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Massage and Foot Reflexology on Newborns' Sleep
- ClinicalTrials.gov ID
- NCT06201962
- Acronym / sponsor ID
- ABozokU
- Conditions
- Preterm Infants, Sleep
- Keywords
- Preterm Infants, Sleep Wake Cycle, Massage, Foot Reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 11 Jan 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.
Purpose: Newborns undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life for various reasons. Leaving the warm, dark, quiet, calm, fluid-filled mother's womb of newborns whose systems are not yet mature and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake pattern required for growth-development and neurodevelopment. It is intensive for the development of newborns' neurosensory systems. They have sleep requirements. It is known that the brain activity of newborns during the intrauterine period is similar to REM (Rapid Eye Movement) sleep activity, they sleep more than adults, and they spend most of their sleep in the REM sleep period. For this reason, our research will be conducted to examine the effects of massage and foot reflexology applied to preterm newborns on sleep.
Design and Methods: This randomized experimental study was carried out on 108 preterm newborns with gestational weeks between 30-37, hospitalized in the neonatal intensive care unit of a city hospital. The researcher was applied massage (n:36) and foot reflexology (n:36) to the newborns for 15 minutes, twice a day for 2 days. No intervention other than routine clinical practices was applied to the control group (n:36). The 24-hour sleep of the newborns included in the study was monitored with a sleep-wakefulness measuring device before the application and on the day the naps end, and was recorded in the newborn follow-up form. Statistical analysis was performed using percentages, means, median, variance and Kruskal Wallis, Wilcoxon tests test.
Detailed description
Sleep is very important for human life and developmentally involves both physiological and mental processes. Sleep is considered not only as a state of rest, but also as a state of intense brain development in which neurotransmitters specific to each sleep stage affect brain maturation . Newborns sleep an average of 16-20 hours a day, spending most of their sleep in the REM (Rapid Eye Movement Phase) sleep period. For this reason, sleep quality in the neonatal period directly affects healthy growth and development. Newborns, who leave the warm, dark, quiet, calm, amniotic fluid-filled mother's womb at birth, undergo biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life due to various reasons .
Babies who leave the intrauterine period early are admitted to technologically equipped neonatal intensive care units. In the neonatal intensive care unit, they are exposed to many stressful stimuli and environmental factors. Premature babies are exposed to painful invasive procedures in the neonatal intensive care unit, negative environmental conditions such as frequent feeding, exposure to high-frequency sounds and constant light negatively affect their sleep-wake cycles.
There are studies in the literature to determine the sleep and wakefulness status of premature babies and the factors affecting them. There are studies examining massage, position and music practices applied to preterm babies. It was observed that the number of babies sleeping was higher in the measurements made after massage therapy in premature babies who received massage and premature babies who did not. Additionally, in his systematic review of massage practice; It has been revealed that it increases mother-baby interaction and positively affects sleep conditions by reducing stress levels and crying .
Today, the use of complementary and alternative medicine treatments is increasing in healthcare systems all over the world. Nurses can use these ways, along with regular treatments, to improve health. In this context, foot reflexology, one of the six most commonly used treatments in complementary medicine, is effective not only in the treatment of diseases but also in protecting health. Reflexology is defined as the science that stimulates the ends of sensory nerves connected to receptors and points related to the internal organs of the body using different degrees of pressure, such as massage and touch. By applying the compression technique to the reflection point of each organ using reflexology, the blockage in the energy flow path is removed and as a result, the energy flows in the movement channels. It has been stated that foot reflexology can improve the physiological index and reduce O2 saturation, heart rate, and inspire relaxation in newborns . There are studies examining the effects of invasive procedures on pain, comfort and physiological parameters .
Developing individualized supportive interventions that ensure deep sleep and wakefulness is important for the quality of care provided to preterm infants. For this reason, it is important to reduce the negativities caused by neonatal intensive care units, improve care, reduce pain caused by invasive procedures and the environment, and ensure the sleep quality and order of premature babies.
There are studies in the literature about the effects of massage and foot reflexology on pain, comfort and vital signs in preterm babies, but no study has been found comparing these methods and examining their effects on sleep. In the literature review, while there are studies in which parents subjectively evaluate children's sleep, no other studies were found in which premature babies' sleep is measured objectively. Therefore, it will be carried out to examine the effects of massage and foot reflexology applied to premature babies on sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study used a randomized controlled trial. A parallel trial design was used describing two different experimental groups (Massage and Foot Reflexology) and a control group
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: MassageBefore the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information will be given about the massage to be performed on the newborn. Before applying massage to premature babies, their 24-hour sleep duration will be evaluated with an actigraphy device. Starting from the face with gentle touches, massage will be applied to the baby's forehead, around the eyes and cheeks with 2 fingers, without pressing too much. Then, the chest area will be massaged with circular movements from right to left, and then the upper and lower extremities will be massaged. Finally, the massage will be completed by turning the baby face down and applying gentle pressure to the back area. Massage applications will be performed for 15 minutes every morning and evening for two days. On the morning of the second day, an actigraphy device will be attached to the premature babies' ankles and their 24-hour sleep will be re-evaluated. |
| Foot Reflexology | Experimental | Other: Foot ReflexologyBefore the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information will be given about the foot reflexology to be performed on the newborn. In addition to daily routine nursing care and monitoring for premature babies, before applying foot reflexology, the actigraphy device will be attached to the babies' ankles and their 24-hour sleep duration will be evaluated. In the reflexology group, the researcher will hold the baby's foot with his left hand and gently massage each foot with the thumb of his right hand for 15 minutes. Foot reflexology will be performed for 15 minutes every morning and evening for two days. On the morning of the second day, an actigraphy device will be attached to the premature babies' ankles and their 24-hour sleep will be re-evaluated. |
| Control | Experimental | Other: ControlNewborns will receive routine medical treatment and nursing care and will not undergo any procedures. Before the procedure, written and verbal consent will be obtained from the newborn's guardian and brief information about the study will be given. Premature babies will have their 24-hour sleep recorded with actigraphy 1 day in advance. Then, the nursing care that premature babies receive in their daily routine will be given for two days. On the morning of the second day, an actigraphy device will be attached to the left foot of the premature babies and their 24-hour sleep on the second day will be recorded. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Those born between 30-37 weeks of gestation and hospitalized in the Neonatal Intensive Care Unit
Key exclusion criteria (7 listed)
- Those whose vital signs are stable
- Those with foot anomalies or those who underwent outpatient surgery
- Those dependent on high-frequency mechanical ventilation
- Those receiving sedative treatment
- Those with hyperbilirubinemia
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 |
|---|---|---|
| MassageMassage applications will be performed for 15 minutes every morning and evening for two days. | Other | Massage |
| Foot ReflexologyIn the reflexology group, the researcher will hold the baby's foot with his left hand and gently massage each foot with the thumb of his right hand for 15 minutes. | Other | Foot Reflexology |
| ControlNewborns will receive routine medical treatment and nursing care and will not undergo any procedures. | Other | Control |
Primary outcome
Changes in sleep
Time frame: 24 hours
The researcher will monitor the newborn babies' sleep times with a sleep-wake measurement device for 24 hours and record them in the Newborn Follow-up Form.
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 1 Jan 2025.
- Background: PubMed 33826975de Groot ER, Knoop MS, van den Hoogen A, Wang X, Long X, Pillen S, Benders M, Dudink J. The value of cardiorespiratory parameters for sleep state classification in preterm infants: A systematic review. Sleep Med Rev. 2021 Aug;58:101462. doi: 10.1016/j.smrv.2021.101462. Epub 2021 Mar 14.
- Background: PubMed 35749799Sentner T, Wang X, de Groot ER, van Schaijk L, Tataranno ML, Vijlbrief DC, Benders MJNL, Bartels R, Dudink J. The Sleep Well Baby project: an automated real-time sleep-wake state prediction algorithm in preterm infants. Sleep. 2022 Oct 10;45(10):zsac143. doi: 10.1093/sleep/zsac143.
- Background: PubMed 36078666Firmino C, Rodrigues M, Franco S, Ferreira J, Simoes AR, Castro C, Fernandes JB. Nursing Interventions That Promote Sleep in Preterm Newborns in the Neonatal Intensive Care Units: An Integrative Review. Int J Environ Res Public Health. 2022 Sep 2;19(17):10953. doi: 10.3390/ijerph191710953.
- Background: PubMed 32083554Park J. Sleep Promotion for Preterm Infants in the NICU. Nurs Womens Health. 2020 Feb;24(1):24-35. doi: 10.1016/j.nwh.2019.11.004. Epub 2020 Feb 19.
- Background: PubMed 33859364Uchitel J, Vanhatalo S, Austin T. Early development of sleep and brain functional connectivity in term-born and preterm infants. Pediatr Res. 2022 Mar;91(4):771-786. doi: 10.1038/s41390-021-01497-4. Epub 2021 Apr 15.
- Background: PubMed 33609634Jazayeri Z, Sajadi M, Dalvand H, Zolfaghari M. Comparison of the effect of foot reflexology and body massage on physiological indicators and bilirubin levels in neonates under phototherapy. Complement Ther Med. 2021 Jun;59:102684. doi: 10.1016/j.ctim.2021.102684. Epub 2021 Feb 17.
- Background: PubMed 30786750Baniasadi H, Hosseini SS, Abdollahyar A, Sheikhbardsiri H. Effect of massage on behavioural responses of preterm infants in an educational hospital in Iran. J Reprod Infant Psychol. 2019 Jul;37(3):302-310. doi: 10.1080/02646838.2019.1578866. Epub 2019 Feb 21.
- 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.
Ayşe Belpınar, Phd principal investigator
Bozok 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 Massage and Foot Reflexology in people with Preterm Infants and Sleep, run by Bozok 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 5 inclusion and 7 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 1 Jan 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?
Changes in sleep (time frame: 24 hours). 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 NCT06201962, which also lists 7 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 1 Jan 2025.