NCT04122417

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

October 8, 2019

Last Update Submit

October 9, 2019

Conditions

Keywords

Therapeutic touchyaksongentle human touchmaternal attachmentpreterm baby

Outcome Measures

Primary Outcomes (1)

  • 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.

    Between August 2016 and August 2017

Study Arms (3)

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.

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.

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

Other: The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby

Interventions

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.

Also known as: The Effect Of Yakson Or Gentle Human Touch
Control GroupGentle Human Touch GroupYakson Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • ŞEYDA CAN, PhD

    university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

August 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share