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

Primary Purpose

Venipuncture, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
gentle human touch
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venipuncture focused on measuring NEWBORN, PRETERM, GENTLE HUMAN TOUCH, PAİN

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

gentle human touch

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PRETERM PAİN
Neonatal Infant Pain Scale
MOTHER'S ANXIETY
State-Trait Anxiety Scale

Secondary Outcome Measures

HEART RATE
Measured 3 times in total
OXYGEN SATURATION
Measured 3 times in total
CRYING TIME
measured with a stopwatch

Full Information

First Posted
December 12, 2022
Last Updated
February 13, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05727631
Brief Title
The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
Official Title
The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venipuncture, Pain
Keywords
NEWBORN, PRETERM, GENTLE HUMAN TOUCH, PAİN

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Preterm babies who apply to the blood collection room to draw blood, will be included in the experimental and control group. Randomization was done at www.randomizer.org.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gentle human touch
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
gentle human touch
Other Intervention Name(s)
yok
Intervention Description
Mother will apply gentle human touch touch technique during venous blood collection from preterm babies between 32-37 weeks of gestation
Primary Outcome Measure Information:
Title
PRETERM PAİN
Description
Neonatal Infant Pain Scale
Time Frame
AT THE FIRST MINUTE OF VENİPUNCTURE
Title
MOTHER'S ANXIETY
Description
State-Trait Anxiety Scale
Time Frame
FIVE MINUTES AFTER VENIPUNCTURE
Secondary Outcome Measure Information:
Title
HEART RATE
Description
Measured 3 times in total
Time Frame
AT THE FIRST MINUTE OF VENİPUNCTURE
Title
OXYGEN SATURATION
Description
Measured 3 times in total
Time Frame
AT THE FIRST MINUTE OF VENİPUNCTURE
Title
CRYING TIME
Description
measured with a stopwatch
Time Frame
METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DERYA KILINÇ, 1
Organizational Affiliation
ISTANBUL CERRAHPAŞA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital
City
Istanbul
State/Province
Üsküdar
ZIP/Postal Code
34100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23932956
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
27112434
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
22001561
Citation
Liaw JJ, Yang L, Katherine Wang KW, Chen CM, Chang YC, Yin T. Non-nutritive sucking and facilitated tucking relieve preterm infant pain during heel-stick procedures: a prospective, randomised controlled crossover trial. Int J Nurs Stud. 2012 Mar;49(3):300-9. doi: 10.1016/j.ijnurstu.2011.09.017. Epub 2011 Oct 14.
Results Reference
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Citation
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Citation
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The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture

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