The Effect of Pain Management Education on The Mothers in Newborn

NCT05173662 | Completed

• 1 other identifier: SelcukU-11-2021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study was to determine the effect of non-pharmacological pain management education given to mothers on the use of non-pharmacological methods and anxiety levels of mothers during routine heel blood collection (guthrie screening test) in term newborns. 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.

Conditions

Pain; Procedural Pain; Infant ALL

Keywords

pain; procedural; newborn; heel blood collection procedure; Education on nonpharmacological methods

Outcome Measures

Primary Outcomes (1)

• The mothers' use of non-pharmacological methods

  The mothers' use of non-pharmacological methods during heel blood collection. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The cases of using the methods were determined as yes and no for each method.

  After the process first 10 minute

Secondary Outcomes (1)

• State anxiety level scores of mothers

  Pre-test 5-10 minutes before the process and 10 minutes after the process

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Procedure: Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process

Control Group

NO INTERVENTION

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.

Interventions

Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process PROCEDURE

Theeduvation initiative was implemented by the researcher at least 12 hours ago in the mothers' room and a brochure was given about the education.

Intervention Group

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For newborns;
• 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

You may not qualify if:

• For newborns;
• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

Selcuk University

Konya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37923615 DERIVED

MeSH Terms

Conditions

Pain; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fulya Unvar

  Konya Aksehir State Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention Group Education was given about non-pharmacological methods that can be applied during the heel blood collection procedure in newborns and a brochure was given. Control group: no intervention was made.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 30, 2021
• Study Start: July 10, 2021
• Primary Completion: September 24, 2021
• Study Completion: November 24, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

TU (2)