StressNCT05580874
The Effect of Massage on Stress in Premature Babies
A study testing Massage and Swaddling in people with Stress and Cortisol, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. The stress experienced by premature infants affects the baby's behavior and laboratory findings. Read more about this study
- Who is it for?
- Ages 30 to 37 weeks
- What is being tested?
- Massage and Swaddling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2022to 23 Jun 2023
- 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
- Families being voluntary to participate in the study
- Babies being born between 30 and 36 weeks plus 6 days of gestation
- Postnatal 3-5. premature babies between days
- Not taking analgesics or sedatives
- Absence of congenital anomaly
- Absence of skin disease
Show all 9Show fewer
- The premature babies passing to oral feeding
- Not having a proven sepsis diagnosis
- No need for mechanical ventilator support
Who cannot join
- Having a congenital anomaly
- Presence of skin disease
- Having intracranial bleeding
- Having sepsis
- Receiving phototherapy
- Taking analgesic / sedative type drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Massage on Stress Behaviors and Salivary Cortisol Levels in Premature Babies
The practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. The stress experienced by premature infants affects the baby's behavior and laboratory findings. Massage is an effective application in facilitating the adaptation of premature babies to extrauterine life and ensuring that they are least affected by adverse environmental conditions. Massage in premature babies has an important place in reducing stress and supporting psychological, mental and physiological development as a healthy tactile stimulus.
Read the detailed description
This study was planned to examine the effects of massage on stress behaviors and salivary cortisol levels in premature infants. The research was planned on a randomized controlled experimental. In the research, the group to which massage will be procedure is the experimental group, and the group to which the swaddling procedure will be the control group will form.
- Being tested
- Massage, Swaddling
- Keywords
- Massage, Premature, Stress
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
The babies in the massage group were given a massage once a day.
SwaddlingOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | Infants in the massage group received a ten-minute massage once a day, one hour after the morning feeding (between 9.30-11.30 am). Video recordings were made to observe the stress behaviors of the infants before, during and after the massage. Vital signs will be recorded a minute before the starting of the massage, at fifth minutes during the procedure and a minute after the end of the massage, and a video will be recorded during these processes. A saliva cortisol sample will be taken the massage five minutes before and 30 minutes after the massage. The scores given to the "Newborn Stress Scale" will be evaluated by watching the videos recorded after the procedure by experts in the field. Receives: Other: Massage |
| Control group | Other | Infants in the swaddling group will form the control group. The swaddling process will be done one hour after the babies are feding (between 9.30-11.30 am). Before, during and after the swaddling procedure, the video will be recorded to observe the stress behavior of the babies. A minute before swaddling, video recording will start. Infants will be swaddling for ten minutes and video recording will be continue. After this process, a minute video recording will be made while the baby is not swaddling. Vital signs will be recorded one minute before starting the swaddling at fifth minutes during the procedure, and a minute after the swaddling.
A saliva cortisol sample will be taken five minutes before and 30 minutes after the swaddling. The scores given to the "Newborn Stress Scale" will be evaluated by watching the videos recorded after the procedure by experts in the field. Receives: Other: Swaddling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol levels
Measured: 5 minutes before massage
Salivary cortisol levels
Measured: 5 minutes before swaddling
Salivary cortisol levels
Measured: 30 minutes after massage
Salivary cortisol levels
Measured: 30 minutes after swaddling
"Newborn Stress Scale"
Measured: After the massage
"Newborn Stress Scale"
Measured: After the swaddling
Secondary outcomes (24)
Baby's heart rate
Measured: A minutes before massage
Baby's respiratory rate
Measured: A minutes before massage
Baby's oxygen saturation
Measured: A minutes before massage
Baby's body temperature
Measured: A minutes before massage
Baby's heart rate
Measured: 5th minute of the massage
Baby's respiratory rate
Measured: 5th minute of the massage
Baby's oxygen saturation
Measured: 5th minute of the massage
Baby's body temperature
Measured: 5th minute of the massage
Baby's heart rate
Measured: A minutes after massage
Baby's respiratory rate
Measured: A minutes after massage
Baby's oxygen saturation
Measured: A minutes after massage
Baby's body temperature
Measured: A minutes after massage
Baby's heart rate
Measured: A minutes before swaddling
Baby's respiratory rate
Measured: A minutes before swaddling
Baby's oxygen saturation
Measured: A minutes before swaddling
Baby's body temperature
Measured: A minutes before swaddling
Baby's heart rate
Measured: In the fifth minute of the swaddling
Baby's respiratory rate
Measured: 5th minute of the swaddling
Baby's oxygen saturation
Measured: 5th minute of the swaddling
Baby's body temperature
Measured: 5th minute of the swaddling
Baby's heart rate
Measured: A minutes after swaddling
Baby's respiratory rate
Measured: A minutes after swaddling
Baby's oxygen saturation
Measured: A minutes after swaddling
Baby's body temperature
Measured: A minutes after swaddling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start17 Jun 2022
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Tepecik Training and Research Hospital, Ege University
- Responsible party
- Principal investigator, Pınar Dogan, Izmir Katip Celebi University
- Investigators
- Hatice BAL YILMAZ, Prof., Study director, Ege UniversityPınar DOGAN, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580874
- Sponsor's protocol ID
- 22-1.1T/54
- Status last verified
- May 2024
- First submitted
- 30 Jun 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Massage on Stress Behaviors and Salivary Cortisol Levels in Premature Babies
- ClinicalTrials.gov ID
- NCT05580874
- Acronym / sponsor ID
- 22-1.1T/54
- Keywords
- Massage, Premature, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Tepecik Training and Research Hospital, Ege University
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. The stress experienced by premature infants affects the baby's behavior and laboratory findings. Massage is an effective application in facilitating the adaptation of premature babies to extrauterine life and ensuring that they are least affected by adverse environmental conditions. Massage in premature babies has an important place in reducing stress and supporting psychological, mental and physiological development as a healthy tactile stimulus.
Detailed description
This study was planned to examine the effects of massage on stress behaviors and salivary cortisol levels in premature infants. The research was planned on a randomized controlled experimental. In the research, the group to which massage will be procedure is the experimental group, and the group to which the swaddling procedure will be the control group will form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Other: MassageInfants in the massage group received a ten-minute massage once a day, one hour after the morning feeding (between 9.30-11.30 am). Video recordings were made to observe the stress behaviors of the infants before, during and after the massage. Vital signs will be recorded a minute before the starting of the massage, at fifth minutes during the procedure and a minute after the end of the massage, and a video will be recorded during these processes. A saliva cortisol sample will be taken the massage five minutes before and 30 minutes after the massage. The scores given to the "Newborn Stress Scale" will be evaluated by watching the videos recorded after the procedure by experts in the field. |
| Control group | Other | Other: SwaddlingInfants in the swaddling group will form the control group. The swaddling process will be done one hour after the babies are feding (between 9.30-11.30 am). Before, during and after the swaddling procedure, the video will be recorded to observe the stress behavior of the babies. A minute before swaddling, video recording will start. Infants will be swaddling for ten minutes and video recording will be continue. After this process, a minute video recording will be made while the baby is not swaddling. Vital signs will be recorded one minute before starting the swaddling at fifth minutes during the procedure, and a minute after the swaddling. A saliva cortisol sample will be taken five minutes before and 30 minutes after the swaddling. The scores given to the "Newborn Stress Scale" will be evaluated by watching the videos recorded after the procedure by experts in the field. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Families being voluntary to participate in the study
- Babies being born between 30 and 36 weeks plus 6 days of gestation
- Postnatal 3-5. premature babies between days
- Not taking analgesics or sedatives
- Absence of congenital anomaly
Key exclusion criteria (6 listed)
- Having a congenital anomaly
- Presence of skin disease
- Having intracranial bleeding
- Having sepsis
- Receiving phototherapy
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 |
|---|---|---|
| MassageThe babies in the massage group were given a massage once a day. | Other | Massage group |
| SwaddlingControl group | Other | Control group |
Primary outcome
Salivary cortisol levels
Time frame: 5 minutes before massage
Salivary cortisol levels
Time frame: 5 minutes before swaddling
Salivary cortisol levels
Time frame: 30 minutes after massage
Salivary cortisol levels
Time frame: 30 minutes after swaddling
"Newborn Stress Scale"
Time frame: After the massage
"Newborn Stress Scale"
Time frame: After the swaddling
24 secondary outcomes
Baby's heart rate
Time frame: A minutes before massage
Baby's respiratory rate
Time frame: A minutes before massage
Baby's oxygen saturation
Time frame: A minutes before massage
Baby's body temperature
Time frame: A minutes before massage
Baby's heart rate
Time frame: 5th minute of the massage
Baby's respiratory rate
Time frame: 5th minute of the massage
Baby's oxygen saturation
Time frame: 5th minute of the massage
Baby's body temperature
Time frame: 5th minute of the massage
Baby's heart rate
Time frame: A minutes after massage
Baby's respiratory rate
Time frame: A minutes after massage
Baby's oxygen saturation
Time frame: A minutes after massage
Baby's body temperature
Time frame: A minutes after massage
Baby's heart rate
Time frame: A minutes before swaddling
Baby's respiratory rate
Time frame: A minutes before swaddling
Baby's oxygen saturation
Time frame: A minutes before swaddling
Baby's body temperature
Time frame: A minutes before swaddling
Baby's heart rate
Time frame: In the fifth minute of the swaddling
Baby's respiratory rate
Time frame: 5th minute of the swaddling
Baby's oxygen saturation
Time frame: 5th minute of the swaddling
Baby's body temperature
Time frame: 5th minute of the swaddling
Baby's heart rate
Time frame: A minutes after swaddling
Baby's respiratory rate
Time frame: A minutes after swaddling
Baby's oxygen saturation
Time frame: A minutes after swaddling
Baby's body temperature
Time frame: A minutes after swaddling
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 3 May 2024.
- 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.
Hatice BAL YILMAZ, Prof. study director
Ege University
Pınar DOGAN principal investigator
Izmir Katip Celebi 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 Swaddling in people with Stress and Cortisol, run by Izmir Katip Celebi 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 9 inclusion and 6 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 3 May 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?
Salivary cortisol levels (time frame: 5 minutes before massage). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.