The Effect of Pain Management Education on The Mothers in Newborn
NCT ID: NCT05173662
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2021-07-10
2021-11-24
Brief Summary
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H0= There was no difference between the intervention group who received non-pharmacological pain management education and the control group's level of anxiety and use of non-pharmacological applications.
H1= The use of non-pharmacological methods is different between the intervention group and the control group that received non-pharmacological pain management education.
H2= Anxiety scores of the intervention group that received non-pharmacological pain management education and the control group were different.
H3= Some characteristics and anxiety levels of mothers have an effect on their use of non-pharmacological methods.
It was carried out between July - September 2021 at the Akşehir State Hospital Gynecology and Obstetrics Clinic, which serves in the Akşehir district of Konya province.
Detailed Description
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This study was designed as parallel group, pre-test and post-test randomized controlled trial.
Based on 80% power and 95% confidence level, the sample size was calculated as 32 infants for each group, a total of 64 infants (G\*Power 3.1.9.2).
Randomization In this study, stratified randomization method was applied. Eight blocks of four were created with the permutation-blocked randomization method.
With the computer program (randomized.org), the numbers from 1 to 6 were listed 8 times (6,3,5,2,2,6,6,5) and the combinations were sorted according to this group, and assignments were made to the intervention and control groups.
Blinding The researcher and participant (mothers) could not be blinded since the researcher had to provide training and manage the process before the application. In order to avoid bias in the evaluation of the data, the analysis of the coded data in terms of groups was done by an independent statistician. After the statistical analyzes were completed and the research report was written, the researcher explained the coding of the intervention and control groups. In this way, single blindness was achieved.
In the collection of research data; Introductory Information Form, Non-pharmacological Method Application Checklist and Spielberger State Anxiety Inventory were used. In addition, the mothers in the intervention group were given a brochure on Nonpharmacological Pain Management Education Nonpharmacological Pain Management Education Brochure
This brochure was prepared by the researcher in line with the literature .The brochure contains methods for non-pharmacological pain management that can be applied during procedural painful interventions in newborns. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The brochure contains information and drawings about the methods. The drawings were created by Architect Merve Özkald. Opinions were received from five experts in terms of the content, language, design and visual suitability of the brochure and the Content Validity Index (CGI) was calculated as 0.890.
Data collection Voluntary Informing Consent Form was obtained from the mothers before the study, and the Introductory Information Form was collected from the mothers by the researcher by face-to-face interview method. Between the dates of the study, mothers of newborns who met the inclusion criteria were randomly assigned to intervention and control groups. Heel blood collection in all newborns; The study was carried out between the 24th and 48th hours of the baby's life, in the gynecology and obstetrics clinic, only in the room where the mother and baby stay together, without any intervention to the baby, by removing the clothes from the lower part of the baby in its natural position.
The heel blood collection procedure was applied in such a way that the baby was next to the mother. No non-pharmacological method was used in routine practice during the procedure.
In this study; The heel blood collection procedure was performed by the same nurse working in the NICU for each infant at one time and by taking the same amount of blood from each infant on average.
At least half an hour before the heel blood collection, it was ensured that the babies were fed and their diapers were clean. During the blood collection process; Standardization of the blood collection technique used, the area where the blood was taken (outer side of the right heel), the needle used in the procedure (needle number 21), environmental factors (such as heat, light, noise), used antiseptic solution (70% alcohol) provided.
To the mothers in the intervention group; At least 12 hours before the heel blood collection (guthrie screening test), information was given by the researcher (FU) about the purpose of the heel blood collection procedure and the application process, and the questions, if any, were answered. Afterwards, an average of 25 minutes of education was given through the training brochure prepared by the researcher on non-pharmacological pain management. The education was carried out in a language that the mother could understand, in the form of direct lectures and questions and answers, using the visuals in the brochure.
The mothers in the control group, on the other hand, were informed by the researcher about the purpose of the heel blood collection procedure and the application process at least 12 hours before the guthrie screening test, and their questions were answered, if any, and no other application was made.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Control group: no intervention was made.
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention Group
To the mothers in this group; At least 12 hours before the heel blood collection (guthrie screening test), training was given, lasting 25 minutes, on average, through the training brochure on non-pharmacological pain management prepared by the researcher. The training was carried out in a language that the mother could understand, in the form of direct lectures and questions and answers, using the visuals in the brochure. In the training content; There are five non-pharmacological methods. These;
* Expressed breast milk
* Wrapping
* Skin-to-skin contact
* Cuddling
* They are methods of making calming sounds.
Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process
Theeduvation initiative was implemented by the researcher at least 12 hours ago in the mothers' room and a brochure was given about the education.
Control Group
In the control group, as in the clinical routine, the heel stick procedure was performed in the newborn's own bed next to his mother. No other action has been applied.
No interventions assigned to this group
Interventions
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Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process
Theeduvation initiative was implemented by the researcher at least 12 hours ago in the mothers' room and a brochure was given about the education.
Eligibility Criteria
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Inclusion Criteria
* Being a healthy term newborn (born at 38-42 weeks of gestation)
* A blood sample will be taken for the Guthrie screening test.
* Having the mother with the baby (Gynecology and Obstetrics Clinic) for mothers;
* Volunteering to participate in the study
* Ability to read and write Turkish
* Being over 18 years old
Exclusion Criteria
* Having a congenital anomaly
* Having received any analgesia before the procedure
* IInability to draw blood in one go for mothers;
* Rejection of heel blood collection voluntarily
* Existence of any obstacle that may make communication difficult
38 Weeks
42 Weeks
ALL
Yes
Sponsors
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Selcuk University
OTHER
Responsible Party
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Fatma Taş Arslan
Professor
Principal Investigators
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Fulya Unvar
Role: STUDY_CHAIR
Konya Aksehir State Hospital
Locations
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Selcuk University
Konya, Selcuklu, Turkey (Türkiye)
Selcuk University
Konya, , Turkey (Türkiye)
Countries
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References
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Unvar F, Tas Arslan F. Effectiveness of maternal-targeted training on nonpharmacologic pain management on heel stick sampling: A randomized controlled trial. J Pediatr Nurs. 2023 Nov-Dec;73:e477-e483. doi: 10.1016/j.pedn.2023.10.018. Epub 2023 Nov 3.
Other Identifiers
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SelcukU-11-2021
Identifier Type: -
Identifier Source: org_study_id