Preterm InfantsNCT07522892
Physiological Safety and Behavioral Comfort of Swaddle Bathing in Preterm Infants
A study testing Swaddle Bathing and Conventional Tub Bathing in people with Preterm Infants, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
Background and Purpose: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU). However, traditional tub bathing can be a significant source of stress for these vulnerable infants, potentially leading to fluctuations in body temperature, heart rate, and oxygen… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Swaddle Bathing and Conventional Tub Bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2024to 30 Jun 2026
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 32 and 36 weeks and 6 days
- Birth weight greater than 1,500 grams
- Clinically stable as determined by the attending neonatologist
- Receiving the first bath after birth
Who cannot join
- Major congenital anomalies, such as cyanotic heart disease, gastroschisis, or open spinal defects
- Severe intraventricular hemorrhage (Grade III or IV)
- Skin impairments or open wounds that contraindicate water immersion, including surgical sites
- Continuous use of sedatives or muscle relaxants that may interfere with behavioral assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Swaddle Bathing on Physiological Regulation and Stress-Reducing Behaviors in Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial
Background and Purpose: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU). However, traditional tub bathing can be a significant source of stress for these vulnerable infants, potentially leading to fluctuations in body temperature, heart rate, and oxygen levels. Swaddle bathing-a technique where the infant is wrapped in a light cloth during the bath-is thought to provide a sense of security and better physiological stability.
The goal of this pilot randomized controlled trial is to compare the effects of swaddle bathing versus conventional tub bathing in preterm infants. The researchers want to determine if swaddle bathing is as safe as traditional methods while being more comfortable for the baby.
Read more
Main Questions to Answer:
- Is swaddle bathing non-inferior to (as safe as) conventional tub bathing regarding the infant's physiological stability (e.g., body temperature and heart rate)?
- Does swaddle bathing significantly reduce stress-related behaviors and crying in preterm infants compared to conventional bathing?
Study Design and Procedure:
Participants will be randomly assigned to one of two groups:
- Experimental Group: Infants will receive swaddle bathing, where they remain snugly wrapped in a towel or wrap while being gently immersed in water.
- Control Group: Infants will receive conventional tub bathing according to standard hospital protocols.
During and after the bath, the research team will monitor the infants' vital signs and video-record their behavioral responses (such as facial expressions and limb movements) to evaluate their level of comfort and stress. The results of this study will provide preliminary evidence to help clinical nurses decide the best bathing practices for promoting the neurodevelopmental care of preterm infants.
Read the detailed description
Study Overview:
This pilot randomized controlled trial (RCT) aims to evaluate the physiological safety and behavioral comfort of swaddle bathing compared to conventional tub bathing in preterm infants. The study is designed to provide preliminary evidence on whether swaddle bathing serves as a neurodevelopmental care intervention that maintains thermal and cardiovascular stability while reducing stress-related behaviors during a routine nursing procedure in the Neonatal Intensive Care Unit (NICU).
Research Methodology:
Participants will be recruited from a NICU and randomly assigned to either the experimental group (swaddle bathing) or the control group (conventional tub bathing) using a block randomization method. To ensure safety, all bathing procedures will be conducted by trained neonatal nurses and monitored for any signs of physiological distress.
Intervention Protocols:
Standardized Environmental Conditions To minimize the confounding effects of hunger or satiety on behavioral responses, all baths were scheduled approximately 30 to 60 minutes before the next scheduled feeding (or 1 hour after feeding). To ensure consistency across both groups, all bathing procedures were conducted in a temperature-controlled environment maintained at 25-26°C. A standardized stainless-steel basin (33 cm diameter, 10 cm height) was filled to 80% capacity with water at 39-40°C. The duration of the bathing procedure was strictly limited to 5 minutes for all participants.
- Experimental Group (Swaddle Bathing): The infant is snugly wrapped in a thin cotton cloth or swaddle. While maintaining the wrap, the infant is gently immersed into a tub of warm water (39 to 40°C). The nurse uncoils the wrap only partially to wash specific body parts, ensuring the infant remains contained and secure throughout the process.
- Control Group (Conventional Tub Bathing): The infant is undressed and placed directly into the tub according to standard hospital protocol, with the nurse providing manual support but without the use of a stabilizing wrap.
Data Collection and Outcome Measurement:
The study will record data at three time points: baseline (pre-bath, T0), immediately post-bath (T1), and 10 minutes post-bath (T2).
- Physiological Safety:
- Body Temperature: Measured using a rapid electronic thermometer (verified by the Bureau of Standards, Metrology and Inspection, MOEA; License No. 001618). Axillary temperature was measured, with the device remaining in place for 3-5 minutes after the beep to ensure accuracy.
- Vital Signs Monitoring: Heart rate (HR) and oxygen saturation (SpO2) were measured using a General Electric B105 portable physiological monitor (License No. 022655). The device is calibrated and maintained every six months by biomedical engineers.
- Behavioral Comfort: Infants will be video-recorded to assess stress signals and comfort levels. Blinded observers will use standardized neonatal pain and stress scales (e.g., Anderson Behavioral State Scale) to score the frequency of crying and stress-related motor activities.
Statistical Analysis:
Data will be analyzed using descriptive statistics and generalized estimating equations (GEE) to account for the repeated measures over time. As a pilot study, the results will be used to calculate the effect size required for a future full-scale clinical trial.
- Conditions
- Preterm Infants
- Being tested
- Swaddle Bathing, Conventional Tub Bathing
- Keywords
- swaddle bath, preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swaddle BathingOther
Experimental Group: Swaddle Bathing
The swaddle bathing intervention is a developmental care procedure designed to enhance neurodevelopmental stability. To ensure consistency, the bath is performed 30-60 minutes before or 1 hour after feeding in a 25-26°C temperature-controlled environment. The infant is snugly wrapped in a thin cotton cloth (swaddle) and gently immersed into a standardized stainless-steel basin (33 cm diameter, 10 cm height) filled with 39-40°C water. During the strictly 5-minute procedure, the nurse uncoils the wrap only partially to wash specific body parts. This method distinguishes itself by maintaining the infant in a contained, secure, and flexed midline position throughout the immersion, minimizing physiological and behavioral stress.
Conventional Tub BathingOther
Control Group: Conventional Tub Bathing
Infants in this group receive standard hospital tub bathing. To control for confounding variables, the environment and timing are identical to the experimental group: 30-60 minutes before or 1 hour after feeding at an ambient temperature of 25-26°C. The infant is undressed and placed directly into the same standardized stainless-steel basin (33 cm diameter, 10 cm height) with water at 39-40°C. The nurse provides manual support to the infant's head and body according to standard NICU protocol but without any stabilizing wrap or cloth containment. The procedure is strictly limited to 5 minutes. Unlike the experimental group, the infant's skin is directly exposed to the water and air without the tactile support of a swaddle.
| Study group | Role | What they receive |
|---|---|---|
| Swaddle Bathing | Experimental | Preterm infants in this group will receive swaddle bathing, a developmental care intervention designed to maintain physiological stability and reduce stress during the bathing process. Receives: Other: Swaddle Bathing |
| Conventional Tub Bathing | Active comparator | Preterm infants in this group will receive the standard conventional tub bathing according to the hospital's current clinical protocol. Receives: Other: Conventional Tub Bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Stress Scores
Behavioral stress is assessed using a checklist based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) principles (Als \& McAnulty, 2011), adapted from the Taiwan Society of Neonatology Developmental Care Manual (Taiwan Society of Neonatology, 2021).
Assessment: The frequency of 10 stress-related behaviors (including motor and neurophysiological cues) is recorded during the 5-minute bathing procedure.
Scoring: The Behavioral Stress Score is calculated as the sum of all observed behavioral frequencies. The total score ranges from 0 with no theoretical maximum. A higher cumulative frequency (score) indicates greater behavioral stress in the preterm infant.
Measured: During the 5-minute bathing procedure
Body Temperature
Measured: baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
Secondary outcomes (3)
Heart Rate
Heart rate is monitored using a General Electric (GE) B105 portable physiological monitor (License No. 022655). Data are recorded in beats per minute (bpm). The device undergoes professional calibration and maintenance every six months by biomedical engineers to ensure measurement accuracy.
Measured: baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
Percentage of Crying Time
The percentage of crying time is calculated by dividing the total duration of the infant's crying during the procedure by the total duration of the bathing procedure (5 minutes), and then multiplying by 100 to obtain a percentage (%). A higher percentage indicates greater behavioral distress during the intervention.
Measured: During the 5-minute bathing procedure
oxygen saturation
Oxygen saturation is measured via a General Electric (GE) B105 portable physiological monitor (License No. 022655) and recorded as a percentage (%). The monitor is regularly calibrated and maintained every six months by certified biomedical engineers to ensure consistent data quality during the neonatal bath.
Measured: baseline (pre-bath), immediately post-bath, 10 minutes post-bath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start24 Apr 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying-Mei Liu, Chang Gung University of Science and Technology
- Investigators
- Tsai-Ling Lin, MSN, Principal investigator, Hsinchu MacKay Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522892
- Sponsor's protocol ID
- 23MMHIS389e
- Other IDs
- 20231100016
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun X, Xu J, Zhou R, Liu B, Gu Z. Effectiveness of different bathing methods on physiological indexes and behavioral status of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2023 Oct 13;23(1):507. doi: 10.1186/s12887-023-04280-y.
PubMed 37828460Fernandez D, Antolin-Rodriguez R. Bathing a Premature Infant in the Intensive Care Unit: A Systematic Review. J Pediatr Nurs. 2018 Sep-Oct;42:e52-e57. doi: 10.1016/j.pedn.2018.05.002. Epub 2018 May 18.
PubMed 29779763Chandebois L, Nogue E, Bouschbacher C, Durand S, Masson F, Mesnage R, Nagot N, Cambonie G. Dissemination of newborn behavior observation skills after Newborn Individualized Developmental Care and Assessment Program (NIDCAP) implementation. Nurs Open. 2021 Nov;8(6):3547-3557. doi: 10.1002/nop2.904. Epub 2021 May 6.
PubMed 33956404
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Swaddle Bathing on Physiological Regulation and Stress-Reducing Behaviors in Preterm Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07522892
- Acronym / sponsor ID
- 23MMHIS389e
- Conditions
- Preterm Infants
- Keywords
- swaddle bath, preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Apr 2026 (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: Bathing is a routine but essential part of care for preterm infants in the Neonatal Intensive Care Unit (NICU). However, traditional tub bathing can be a significant source of stress for these vulnerable infants, potentially leading to fluctuations in body temperature, heart rate, and oxygen levels. Swaddle bathing-a technique where the infant is wrapped in a light cloth during the bath-is thought to provide a sense of security and better physiological stability.
The goal of this pilot randomized controlled trial is to compare the effects of swaddle bathing versus conventional tub bathing in preterm infants. The researchers want to determine if swaddle bathing is as safe as traditional methods while being more comfortable for the baby.
Main Questions to Answer:
- Is swaddle bathing non-inferior to (as safe as) conventional tub bathing regarding the infant's physiological stability (e.g., body temperature and heart rate)?
- Does swaddle bathing significantly reduce stress-related behaviors and crying in preterm infants compared to conventional bathing?
Study Design and Procedure:
Participants will be randomly assigned to one of two groups:
- Experimental Group: Infants will receive swaddle bathing, where they remain snugly wrapped in a towel or wrap while being gently immersed in water.
- Control Group: Infants will receive conventional tub bathing according to standard hospital protocols.
During and after the bath, the research team will monitor the infants' vital signs and video-record their behavioral responses (such as facial expressions and limb movements) to evaluate their level of comfort and stress. The results of this study will provide preliminary evidence to help clinical nurses decide the best bathing practices for promoting the neurodevelopmental care of preterm infants.
Detailed description
Study Overview:
This pilot randomized controlled trial (RCT) aims to evaluate the physiological safety and behavioral comfort of swaddle bathing compared to conventional tub bathing in preterm infants. The study is designed to provide preliminary evidence on whether swaddle bathing serves as a neurodevelopmental care intervention that maintains thermal and cardiovascular stability while reducing stress-related behaviors during a routine nursing procedure in the Neonatal Intensive Care Unit (NICU).
Research Methodology:
Participants will be recruited from a NICU and randomly assigned to either the experimental group (swaddle bathing) or the control group (conventional tub bathing) using a block randomization method. To ensure safety, all bathing procedures will be conducted by trained neonatal nurses and monitored for any signs of physiological distress.
Intervention Protocols:
Standardized Environmental Conditions To minimize the confounding effects of hunger or satiety on behavioral responses, all baths were scheduled approximately 30 to 60 minutes before the next scheduled feeding (or 1 hour after feeding). To ensure consistency across both groups, all bathing procedures were conducted in a temperature-controlled environment maintained at 25-26°C. A standardized stainless-steel basin (33 cm diameter, 10 cm height) was filled to 80% capacity with water at 39-40°C. The duration of the bathing procedure was strictly limited to 5 minutes for all participants.
- Experimental Group (Swaddle Bathing): The infant is snugly wrapped in a thin cotton cloth or swaddle. While maintaining the wrap, the infant is gently immersed into a tub of warm water (39 to 40°C). The nurse uncoils the wrap only partially to wash specific body parts, ensuring the infant remains contained and secure throughout the process.
- Control Group (Conventional Tub Bathing): The infant is undressed and placed directly into the tub according to standard hospital protocol, with the nurse providing manual support but without the use of a stabilizing wrap.
Data Collection and Outcome Measurement:
The study will record data at three time points: baseline (pre-bath, T0), immediately post-bath (T1), and 10 minutes post-bath (T2).
- Physiological Safety:
- Body Temperature: Measured using a rapid electronic thermometer (verified by the Bureau of Standards, Metrology and Inspection, MOEA; License No. 001618). Axillary temperature was measured, with the device remaining in place for 3-5 minutes after the beep to ensure accuracy.
- Vital Signs Monitoring: Heart rate (HR) and oxygen saturation (SpO2) were measured using a General Electric B105 portable physiological monitor (License No. 022655). The device is calibrated and maintained every six months by biomedical engineers.
- Behavioral Comfort: Infants will be video-recorded to assess stress signals and comfort levels. Blinded observers will use standardized neonatal pain and stress scales (e.g., Anderson Behavioral State Scale) to score the frequency of crying and stress-related motor activities.
Statistical Analysis:
Data will be analyzed using descriptive statistics and generalized estimating equations (GEE) to account for the repeated measures over time. As a pilot study, the results will be used to calculate the effect size required for a future full-scale clinical trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swaddle Bathing | Experimental | Other: Swaddle BathingPreterm infants in this group will receive swaddle bathing, a developmental care intervention designed to maintain physiological stability and reduce stress during the bathing process. |
| Conventional Tub Bathing | Active comparator | Other: Conventional Tub BathingPreterm infants in this group will receive the standard conventional tub bathing according to the hospital's current clinical protocol. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age between 32 and 36 weeks and 6 days
- Birth weight greater than 1,500 grams
- Clinically stable as determined by the attending neonatologist
- Receiving the first bath after birth
Key exclusion criteria (4 listed)
- Major congenital anomalies, such as cyanotic heart disease, gastroschisis, or open spinal defects
- Severe intraventricular hemorrhage (Grade III or IV)
- Skin impairments or open wounds that contraindicate water immersion, including surgical sites
- Continuous use of sedatives or muscle relaxants that may interfere with behavioral assessments
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 |
|---|---|---|
| Swaddle BathingExperimental Group: Swaddle Bathing The swaddle bathing intervention is a developmental care procedure designed to enhance neurodevelopmental stability. To ensure consistency, the bath is performed 30-60 minutes before or 1 hour after feeding in a 25-26°C temperature-controlled environment. The infant is snugly wrapped in a thin cotton cloth (swaddle) and gently immersed into a standardized stainless-steel basin (33 cm diameter, 10 cm height) filled with 39-40°C water. During the strictly 5-minute procedure, the nurse uncoils the wrap only partially to wash specific body parts. This method distinguishes itself by maintaining the infant in a contained, secure, and flexed midline position throughout the immersion, minimizing physiological and behavioral stress. | Other | Swaddle Bathing |
| Conventional Tub BathingControl Group: Conventional Tub Bathing Infants in this group receive standard hospital tub bathing. To control for confounding variables, the environment and timing are identical to the experimental group: 30-60 minutes before or 1 hour after feeding at an ambient temperature of 25-26°C. The infant is undressed and placed directly into the same standardized stainless-steel basin (33 cm diameter, 10 cm height) with water at 39-40°C. The nurse provides manual support to the infant's head and body according to standard NICU protocol but without any stabilizing wrap or cloth containment. The procedure is strictly limited to 5 minutes. Unlike the experimental group, the infant's skin is directly exposed to the water and air without the tactile support of a swaddle. | Other | Conventional Tub Bathing |
Primary outcome
Behavioral Stress Scores
Time frame: During the 5-minute bathing procedure
Behavioral stress is assessed using a checklist based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) principles (Als \& McAnulty, 2011), adapted from the Taiwan Society of Neonatology Developmental Care Manual (Taiwan Society of Neonatology, 2021). Assessment: The frequency of 10 stress-related behaviors (including motor and neurophysiological cues) is recorded during the 5-minute bathing procedure. Scoring: The Behavioral Stress Score is calculated as the sum of all observed behavioral frequencies. The total score ranges from 0 with no theoretical maximum. A higher cumulative frequency (score) indicates greater behavioral stress in the preterm infant.
Body Temperature
Time frame: baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
3 secondary outcomes
Heart Rate
Time frame: baseline (pre-bath), immediately post-bath, and 10 minutes post-bath.
Percentage of Crying Time
Time frame: During the 5-minute bathing procedure
oxygen saturation
Time frame: baseline (pre-bath), immediately post-bath, 10 minutes post-bath
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 22 Oct 2026.
- Background: PubMed 37828460Sun X, Xu J, Zhou R, Liu B, Gu Z. Effectiveness of different bathing methods on physiological indexes and behavioral status of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2023 Oct 13;23(1):507. doi: 10.1186/s12887-023-04280-y.
- Background: PubMed 29779763Fernandez D, Antolin-Rodriguez R. Bathing a Premature Infant in the Intensive Care Unit: A Systematic Review. J Pediatr Nurs. 2018 Sep-Oct;42:e52-e57. doi: 10.1016/j.pedn.2018.05.002. Epub 2018 May 18.
- Background: PubMed 33956404Chandebois L, Nogue E, Bouschbacher C, Durand S, Masson F, Mesnage R, Nagot N, Cambonie G. Dissemination of newborn behavior observation skills after Newborn Individualized Developmental Care and Assessment Program (NIDCAP) implementation. Nurs Open. 2021 Nov;8(6):3547-3557. doi: 10.1002/nop2.904. Epub 2021 May 6.
- Individual participant dataSharing planned: No
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Tsai-Ling Lin, MSN principal investigator
Hsinchu MacKay Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swaddle Bathing and Conventional Tub Bathing in people with Preterm Infants, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
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 4 inclusion and 4 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 22 Oct 2026. 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 Taiwan. 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?
Behavioral Stress Scores (time frame: During the 5-minute bathing procedure). The study lists 2 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 NCT07522892, which also lists 3 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 22 Oct 2026.