Therapeutic TouchNCT04122417
The Effect Of Therapeutic Touch To Mothers With Preterm Babies
An observational study of Therapeutic Touch, run by University of Yalova.
Trial summary
The study was carried to determine the effect of yakson or gentle human touch methods applied by the mothers to their preterm newborns on mother's attachment level and baby's response. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Touch
- What is being tested?
- The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Aug 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sample of the study consists of babies and their mothers who were matching the criteria of the research between these dates and who volunteered. As a result of the power analysis, sample size was calculated as 90 for experimental and control groups with Power: 0.80. As a result of the sample calculation a total of 90 mothers and babies; 30 for Yakson group, 30 for gentle human touch group, 30 for control group were included in the study. The assignment of mothers and babies to the experiment and control groups was carried out by randomization with drawing lots method.
Who may be able to join
- Mothers' Selection Criteria
- Mother should not have any defines psychiatric diseases,
- Mother should not have any physical disabilities,
- Mother should be literate and open to communication,
- Should not have transportation problem,
- Should be willing to participate and volunteer for the study.
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- Babies' Selection Criteria
- Babies should be between 26-34 gestation weeks,
- Should not have congenital abnormalities,
- Babies should not have any health problems that may hinder the practice (Intracranial hemorrhage, sepsis, hemorrhagic diseases, having an operation, etc.).
Who cannot join
- -Participants must have inclusion criterias.
About this study
Official title: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby
The study was carried to determine the effect of yakson or gentle human touch methods applied by the mothers to their preterm newborns on mother's attachment level and baby's response.
Read the detailed description
The study was carried out as a randomized controlled experimental research. Population of the study is all of the babies who were hospitalized at the neonatal intensive care unit of a state hospital in Turkey between August 2016 and August 2017 and the mothers of the babies; its sample is 90 mothers and their babies included with randomization method who were matching the criteria who were also hospitalized between these dates.
- Conditions
- Therapeutic Touch
- Being tested
- The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby
- Keywords
- Therapeutic touch, yakson, gentle human touch, maternal attachment, preterm baby
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The BabyOther
Also called The Effect Of Yakson Or Gentle Human Touch
The study was carried out as randomized experiment to determine the effect of Yakson or Gentle Human Touch method practiced by mothers to preterm newborns on the maternal attachment level and the baby's responses.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The mothers and infants in the experimental and control groups were assigned to the groups by randomization method. Therapeutic touch didn't apllied to control group.
Babies in the control group who took care practices in accordance with normal hospital procedures. Receives: Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby | |
| Yakson Group | The touch method was taught to the mothers in the Yakson group by the researcher in the first three days after the birth with the training brochure, video and applications on the model that are prepared in accordance with expert opinion.
In yakson method, mother's fingers are closed, and she should touch in a way that does not apply excessive pressure. The method is applied for a total of 15 minutes in three cycles. First 5 minutes is resting the hand, 5 minutes is gentle caressing, and another 5 minutes of resting the hand. Receives: Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby | |
| Gentle Human Touch Group | The touch method was taught to the mothers in the Gentle Human Touch group by the researcher in the first three days after the birth with the training brochure, video and applications on the model that are prepared in accordance with expert opinion.
Mother slowly places one hand on the baby's hand and the other over pelvic cavity, covering the waist and hips of the baby.
The touch is preserved for 15 minutes. In order to ensure equal touch for the duration of gentle human touch, the mother sits on a stool and her elbows have to be at the same level with baby's bed Receives: Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby
Study was determined that therapeutic touch methods applied to babies by the mothers increase mother-baby attachment; contributed to the sleep-calmness states, vital signs and weight gain of the baby; and reduced the stays in hospital.
Measured: Between August 2016 and August 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Aug 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic TouchStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda Can, University of Yalova
- Investigators
- ŞEYDA CAN, PhD, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122417
- Sponsor's protocol ID
- YALOVA ÜNİVERSİTESİ
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby
- ClinicalTrials.gov ID
- NCT04122417
- Acronym / sponsor ID
- YALOVA ÜNİVERSİTESİ
- Conditions
- Therapeutic Touch
- Keywords
- Therapeutic touch, yakson, gentle human touch, maternal attachment, preterm baby
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 10 Oct 2019 (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 study was carried to determine the effect of yakson or gentle human touch methods applied by the mothers to their preterm newborns on mother's attachment level and baby's response.
Detailed description
The study was carried out as a randomized controlled experimental research. Population of the study is all of the babies who were hospitalized at the neonatal intensive care unit of a state hospital in Turkey between August 2016 and August 2017 and the mothers of the babies; its sample is 90 mothers and their babies included with randomization method who were matching the criteria who were also hospitalized between these dates.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The BabyThe mothers and infants in the experimental and control groups were assigned to the groups by randomization method. Therapeutic touch didn't apllied to control group. Babies in the control group who took care practices in accordance with normal hospital procedures. |
| Yakson Group | – | Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The BabyThe touch method was taught to the mothers in the Yakson group by the researcher in the first three days after the birth with the training brochure, video and applications on the model that are prepared in accordance with expert opinion. In yakson method, mother's fingers are closed, and she should touch in a way that does not apply excessive pressure. The method is applied for a total of 15 minutes in three cycles. First 5 minutes is resting the hand, 5 minutes is gentle caressing, and another 5 minutes of resting the hand. |
| Gentle Human Touch Group | – | Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The BabyThe touch method was taught to the mothers in the Gentle Human Touch group by the researcher in the first three days after the birth with the training brochure, video and applications on the model that are prepared in accordance with expert opinion. Mother slowly places one hand on the baby's hand and the other over pelvic cavity, covering the waist and hips of the baby. The touch is preserved for 15 minutes. In order to ensure equal touch for the duration of gentle human touch, the mother sits on a stool and her elbows have to be at the same level with baby's bed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample of the study consists of babies and their mothers who were matching the criteria of the research between these dates and who volunteered. As a result of the power analysis, sample size was calculated as 90 for experimental and control groups with Power: 0.80. As a result of the sample calculation a total of 90 mothers and babies; 30 for Yakson group, 30 for gentle human touch group, 30 for control group were included in the study. The assignment of mothers and babies to the experiment and control groups was carried out by randomization with drawing lots method.
Key inclusion criteria (10 listed)
- Mothers' Selection Criteria
- Mother should not have any defines psychiatric diseases,
- Mother should not have any physical disabilities,
- Mother should be literate and open to communication,
- Should not have transportation problem,
Key exclusion criteria (1 listed)
- -Participants must have inclusion criterias.
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 |
|---|---|---|
| The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The BabyAlso: The Effect Of Yakson Or Gentle Human TouchThe study was carried out as randomized experiment to determine the effect of Yakson or Gentle Human Touch method practiced by mothers to preterm newborns on the maternal attachment level and the baby's responses. | Other | Control Group, Gentle Human Touch Group, Yakson Group |
Primary outcome
The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby
Time frame: Between August 2016 and August 2017
Study was determined that therapeutic touch methods applied to babies by the mothers increase mother-baby attachment; contributed to the sleep-calmness states, vital signs and weight gain of the baby; and reduced the stays in hospital.
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 14 Oct 2019.
- 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.
ŞEYDA CAN, PhD principal investigator
university
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Touch, run by University of Yalova.
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 10 inclusion and 1 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby (time frame: Between August 2016 and August 2017). 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 14 Oct 2019.