The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture

February 13, 2023 updated by: DERYA KILINÇ, Istanbul University - Cerrahpasa (IUC)

Newborns are frequently exposed to acute or chronic pain experience due to different invasive interventions. The American Academy of Pediatrics (AAP) recommends minimizing the pain associated with invasive procedures. Reduction of pain primarily requires accurate assessment of pain, and treatment with pharmacological/nonpharmacological interventions.

Touch is one of the first senses developed in the newborn. Gentle Human Touch (Gentle Human Touch) is one of the therapeutic touch methods. Gentle touch, which is a simple and applicable method in newborns, is a non-invasive touch technique that does not require special equipment and technology. The gentle touch method is a sensitive tactile stimulation applied to the skin, without stroking or massage, and provides a relaxing effect on the baby. Studies have shown that the gentle touch method increases the sleep level of preterm infants, reduces pain, stress and cortisone levels, reduces restlessness and keeps the heart rate under control.

Newborns need their parents, especially their mothers, to be by their side during any kind of intervention. For this reason, the presence of the parent next to the newborn during invasive procedures and the primary role in nonpharmacological interventions provides optimal comfort for the nurse, the newborn and the caregiver. When using nonpharmacological methods, it is important to take advantage of the family-centered care model. Family-centered care is a model of care based on cooperation between health professionals and children's families in the planning, delivery and evaluation of health Decency. Its general objective is to improve the quality of health services for children and families, to increase the satisfaction of families and health professionals, and to ensure the effective use of personnel.

Accordingly, this thesis study was planned in a randomized controlled experimental design type in order to determine the importance of family-centered care model and parents' participation in the procedures and the effect of gentle touch method applied by mothers during bloodletting on preterm pain level, physiological parameters, crying time and anxiety level of the mother.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

June December 2021-Dec 2021, the universe of the research will consist of preterm infants and mothers admitted to Istanbul Zeynep Kamil Women and Children's Diseases Training and Research Hospital Neonatal Outpatient Clinic. The sample will be composed of mothers and preterm infants who have undergone bloodletting between these dates, who meet the sample selection criteria, and who volunteer to participate in the study Dec. At the beginning of the data collection phase, power analysis will be performed to determine the number of samples. Groups of babies will be determined using simple randomization method in computer environment.

Data Collection Process After obtaining the permissions of the ethics committee and the institution of the research, the subject and purpose of the research will be explained to all medical personnel working in the neonatal outpatient clinic of the hospital where the research will be conducted, and the methods to be applied in the research will be explained. After the parents of the babies who meet the case selection criteria are informed about the research, their oral and written consents will be obtained through the "Informed Consent Form". It will be determined by computerized simple randomization method which mothers and their babies who are willing to participate in the research and who meet the sample selection criteria will be included in which group (www.randomizer.org ). The experimental group and the control group will be fitted with a pulse oximeter device 5 minutes before the start of the blood collection procedure and it will be ensured that it is attached until 5 minutes after the procedure. 5 Minutes before the procedure, the procedure sequence and 5 minutes after the procedure, the baby's pain score, the number of heart beats, the oxygen saturation value and the mother's anxiety level will be recorded. The crying time will be recorded as the time elapsed from the moment the baby starts crying until the crying ends. All measurements will be measured by two independent observers and recorded in the observation form. The blood collection procedure will be performed by the same nurse in each of the 2 groups.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34100
        • Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 8 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 32 and 37 gestational weeks,
  • The first blood collection attempt is successful,
  • Health follow-ups performed after childbirth are considered healthy by the physician,

Exclusion Criteria:

  • Analgesic given up to 6 hours before the procedure,
  • With a congenital anomaly, • With any disease,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: gentle human touch
In the study, after the mother in the experimental group was dressed in a clean apron, she was allowed to wash and disinfect her hands. When the temperature of the mother's hand was measured with a non-contact thermometer, it was allowed to warm it under a radiant heater until it reached 34 ºC. The mother, who was informed about the method before, was allowed to place the palm of one hand on the baby's crown, with her fingertips touching the eyebrow line. She placed her other hand on her lower abdomen, encircling the baby's waist and hips. It has been provided to perform sensitive touch operation without pressure and massage. The mother started the gentle touch method 5 minutes before the blood draw, and continued to do the touching during the blood draw and 5 minutes after the blood draw was finished.
Other: gentle human touch
Mother will apply gentle human touch touch technique during venous blood collection from preterm babies between 32-37 weeks of gestation
Other Names:
  • yok
NO_INTERVENTION: Control group

The standard procedure of the clinic was applied to preterm infants in the control group. In the standard procedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure.

IN ALL BABIES IN THE CONTROL AND EXPERIMENTAL GROUP., Before the procedure, 5 minutes after the procedure and 20 minutes after the procedure, the mother filled out the STAI-I form. The NIPS scale to measure the infant's pain was scored by two independent observers before, during, and five minutes after the procedure. KTA, SPO2 values of the baby were recorded before, during and five minutes after the procedure. The baby's crying time was started when the crying started, and stopped when the crying stopped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRETERM PAİN
Time Frame: AT THE FIRST MINUTE OF VENİPUNCTURE
Neonatal Infant Pain Scale
AT THE FIRST MINUTE OF VENİPUNCTURE
MOTHER'S ANXIETY
Time Frame: FIVE MINUTES AFTER VENIPUNCTURE
State-Trait Anxiety Scale
FIVE MINUTES AFTER VENIPUNCTURE

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HEART RATE
Time Frame: AT THE FIRST MINUTE OF VENİPUNCTURE
Measured 3 times in total
AT THE FIRST MINUTE OF VENİPUNCTURE
OXYGEN SATURATION
Time Frame: AT THE FIRST MINUTE OF VENİPUNCTURE
Measured 3 times in total
AT THE FIRST MINUTE OF VENİPUNCTURE
CRYING TIME
Time Frame: METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED
measured with a stopwatch
METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: DERYA KILINÇ, 1, Istanbul Cerrahpaşa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2021

Primary Completion (ACTUAL)

August 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

February 13, 2023

First Posted (ESTIMATE)

February 14, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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