The Effects on Pain of Acupressure and Foot Reflexology Before Heel Lancing in Newborns

NCT ID: NCT04643730

Last Updated: 2020-11-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2018-03-30

Brief Summary

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This study aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns.

Detailed Description

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Conditions

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Interventions Pain

Keywords

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Newborn, pain, heel lance, foot reflexology, acupressure, nurse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Reflexology Group

Foot Reflexology was applied to the babies before heel lancing

Group Type EXPERIMENTAL

Foot Reflexology Methods

Intervention Type OTHER

Foot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick

Acupressure Group

Acupressure was applied to the babies before heel lancing

Group Type EXPERIMENTAL

Acupressure methods

Intervention Type OTHER

Acupressure on the KI3 and St36 points applied to the babies in the acupressure group for a total of 7 minutes before the heel prick

Control Group

No pre-application was made to the babies in the control group as a routine procedure

Group Type ACTIVE_COMPARATOR

Control Grup

Intervention Type OTHER

No pre-application was made to the babies in the control group as a routine procedure.

Interventions

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Acupressure methods

Acupressure on the KI3 and St36 points applied to the babies in the acupressure group for a total of 7 minutes before the heel prick

Intervention Type OTHER

Foot Reflexology Methods

Foot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick

Intervention Type OTHER

Control Grup

No pre-application was made to the babies in the control group as a routine procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Being born by cesarean section,
2. Being a term newborn,
3. Being completed the 24th hour of the postnatal period,
4. Staying with birth mother,
5. Being fed in the last half hour before the procedure,
6. Having a heel prick performed by the same nurse,
7. Giving blood on the first try (because pain level may change on the second try),
8. Having a mother who gave written informed consent

Exclusion Criteria

1. Having no health problem,
2. Being underwent more than 2 invasive interventions,
3. Receiving an analgesic/sedative drug in the 8 hours before the application.
Minimum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Özge DENİZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Afyonkarahisar Public Hospital

Afyonkarahisar, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.

Reference Type BACKGROUND
PMID: 18165830 (View on PubMed)

Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.

Reference Type BACKGROUND
PMID: 19924132 (View on PubMed)

Açıkgöz, A., Çiğdem, Z., Yıldız, S., Demirüstü, C., Yarar, M., & Aksit, A. (2017). A Turkish Adaptation of the Neonatal Pain/Agitation, Sedation Scale (N-PASS) and its Validity and Reliability, Indian Journal of Fundamental and Applied Life Sciences, 7(2): 5-11

Reference Type BACKGROUND

Deniz AO, Acikgoz A. A Randomized Controlled Trial: The Effect of Acupressure and Foot Reflexology on Pain During Heel-Lancing in Neonates. Clin Nurs Res. 2023 Feb;32(2):306-312. doi: 10.1177/10547738211061815. Epub 2021 Dec 26.

Reference Type DERIVED
PMID: 34955035 (View on PubMed)

Other Identifiers

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Ayşe Özge DENİZ

Identifier Type: -

Identifier Source: org_study_id