Effect of Acupressure on Interventional Pain in Infants

NCT05166551 | Completed

• 1 other identifier: Effect of Acupressure on Pain
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to investigate the effect of acupressure, to be applied to the GallBladder (GB) 31 "Fengshi" acupuncture point before the vaccinations, on interventional pain caused by the vaccinations in infants. Considering the literature, it can be seen that acupressure is used in many fields and it's among the non-pharmacological methods that have been used by nurses in recent years.However, no study has been found to be conducted on the effect of acupressure, applied before the vaccine, on interventional pain caused by the vaccinations in infants. Therefore, this study aims to investigate the effect of acupressure applied before the vaccination on interventional pain in infants.

Conditions

Procedural Pain; Child, Only

Keywords

Infant; Procedural Pain; Acupressure

Outcome Measures

Primary Outcomes (1)

• Pain severity

  The parents will informed about the FLACC pain scale and they will asked to mark the children's pain levels on the scale. In addition, the pain levels of the children will determined by the researcher and a nurse who is a specialist in pediatric nursing by using the same scale.

  Starting with the vaccination and up to 1 minute after the procedure

Secondary Outcomes (3)

• Heart rate (HR)

  Before (1 minute), during and after (1 minute) the procedure

• Peripheral oxygen saturation level (SPO2)

  Before (1 minute), during and after (1 minute) the procedure

• Criying time

  After the procedure (1 minute)

Study Arms (3)

Experimental Group

EXPERIMENTAL

Acupressure will be applied to the infants in this group by the researcher in accordance with the technique for 1 minute on the GB31 acupuncture point on the leg where the vaccine will be administered.The considerations before, during and after acupressure application are as follows: * The hands will be washed to warm them up to body temperature. * The acupressure will be applied using the thumb to the GB31 acupuncture point for 1 minute before the vaccine is administered to the infants in the experimental group. * Pain scoring will be performed using the FLACC scale by the parents, the observing nurse, and the researcher after the vaccination procedure. In addition, the HR and SPO2 level of the infants before, during and after the procedure will be evaluated and recorded by the researcher.The crying time of infants will also be recorded.

Procedure: Acupressure

Placebo Group

PLACEBO COMPARATOR

Pressure will be applied by the researcher on a placebo point at least 2 cun above the GB31 acupuncture point, on the leg to be vaccinated, for 1 minute. The considerations before, during and after pressure are as follows: * The hands will be washed to warm them up to body temperature. * For the infants in the placebo group, pressure will be applied using the thumb for 1 minute to a placebo point that does not coincide with any acupuncture point at least 2 cun above the acupuncture point before the vaccine is administered. * Pain scoring will be performed using the FLACC scale by the parents, the observing nurse, and the researcher after the vaccination procedure. In addition, the HR and SPO2 level of the infants before, during and after the procedure will be evaluated and recorded by the researcher.The crying time of infants will also be recorded.

Procedure: Placebo Acupressure

Control Group

NO INTERVENTION

The considerations before, during and after are as follows: Without any intervention, the infants in this group pain scoring will be performed using the FLACC scale by the parents, the observing nurse, and the researcher after the vaccination procedure. In addition, the HR and SPO2 level of the infants before, during and after the procedure will be evaluated and recorded by the researcher.The crying time of infants will also be recorded.

Interventions

Acupressure PROCEDURE

This study will be conducted in a randomized placebo-controlled research design to investigate the effect of acupressure, to be applied to the Gall Bladder (GB) 31 "Fengshi" acupuncture point before the vaccinations, on interventional pain in infants (0-1 years) caused by the vaccine.

Experimental Group

Placebo Acupressure PROCEDURE

Placebo Acupressure

Placebo Group

Eligibility Criteria

• Age: 5 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being healthy
• To be older than 4 weeks
• To be less than 1 year old
• Parents' consent to participate in the study
• To be born between 38-42 gestational weeks
• To take part in the routine vaccination program of the Ministry of Health

You may not qualify if:

• Being a sick infant
• To be over 1 year old
• Have taken analgesics in the last 4 hours
• To be born lower than 37 gestational weeks
• Parents' don't consent to participate in the study

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

• Abbasoglu A, Cabioglu MT, Tugcu AU, Ince DA, Tekindal MA, Ecevit A, Tarcan A. Acupressure at BL60 and K3 Points Before Heel Lancing in Preterm Infants. Explore (NY). 2015 Sep-Oct;11(5):363-6. doi: 10.1016/j.explore.2015.07.005. Epub 2015 Jul 3.

  PMID: 26242287 BACKGROUND

• Bastani F, Khosravi M, Borimnejad L, Arbabi N. The effect of acupressure on cancer-related fatigue among school-aged children with acute lymphoblastic leukemia. Iran J Nurs Midwifery Res. 2015 Sep-Oct;20(5):545-51. doi: 10.4103/1735-9066.164508.

  PMID: 26457090 BACKGROUND

• Carotenuto M, Gallai B, Parisi L, Roccella M, Esposito M. Acupressure therapy for insomnia in adolescents: a polysomnographic study. Neuropsychiatr Dis Treat. 2013;9:157-62. doi: 10.2147/NDT.S41892. Epub 2013 Jan 24.

  PMID: 23378768 BACKGROUND

• Das R, Nayak BS, Margaret B. Acupressure and physical stress among high school students. Holist Nurs Pract. 2011 Mar-Apr;25(2):97-104. doi: 10.1097/HNP.0b013e31820d784a.

  PMID: 21325910 BACKGROUND

• Jones E, Isom S, Kemper KJ, McLean TW. Acupressure for chemotherapy-associated nausea and vomiting in children. J Soc Integr Oncol. 2008 Fall;6(4):141-5.

  PMID: 19134445 BACKGROUND

• Koc Ozkan T, Simsek Kucukkelepce D, Aydin Ozkan S. The effects of acupressure and foot massage on pain during heel lancing in neonates: A randomized controlled trial. Complement Ther Med. 2019 Oct;46:103-108. doi: 10.1016/j.ctim.2019.08.004. Epub 2019 Aug 6.

  PMID: 31519265 BACKGROUND

• Liu CF, Chien LW. Efficacy of acupuncture in children with asthma: a systematic review. Ital J Pediatr. 2015 Jul 7;41:48. doi: 10.1186/s13052-015-0155-1.

  PMID: 26149519 BACKGROUND

• Norheim AJ, Liodden I, Howley M. Implementation of acupuncture and acupressure under surgical procedures in children: a pilot study. Acupunct Med. 2010 Jun;28(2):71-3. doi: 10.1136/aim.2009.002220. Epub 2010 May 10.

  PMID: 20458123 BACKGROUND

• Tanju O, Fatma Yilmaz K. Effect of acupressure on procedural pain before heel lancing in neonates. J Tradit Chin Med. 2021 Apr;41(2):331-337.

  PMID: 33825415 BACKGROUND

• Pour PS, Ameri GF, Kazemi M, Jahani Y. Comparison of Effects of Local Anesthesia and Two-Point Acupressure on the Severity of Venipuncture Pain Among Hospitalized 6-12-Year-Old Children. J Acupunct Meridian Stud. 2017 Jun;10(3):187-192. doi: 10.1016/j.jams.2017.04.001. Epub 2017 Apr 24.

  PMID: 28712478 BACKGROUND

• Tugcu AU, Cabioglu T, Abbasoglu A, Ecevit A, Ince DA, Tarcan A. Evaluation of peripheral perfusion in term newborns before and after Yintang (EX-HN 3) massage. J Tradit Chin Med. 2015 Dec;35(6):642-5. doi: 10.1016/s0254-6272(15)30153-9.

  PMID: 26742308 BACKGROUND

• Wang SM, Escalera S, Lin EC, Maranets I, Kain ZN. Extra-1 acupressure for children undergoing anesthesia. Anesth Analg. 2008 Sep;107(3):811-6. doi: 10.1213/ane.0b013e3181804441.

  PMID: 18713889 BACKGROUND

• Yeh CH, Chien LC, Chiang YC, Lin SW, Huang CK, Ren D. Reduction in nausea and vomiting in children undergoing cancer chemotherapy by either appropriate or sham auricular acupuncture points with standard care. J Altern Complement Med. 2012 Apr;18(4):334-40. doi: 10.1089/acm.2011.0102.

  PMID: 22515794 BACKGROUND

• Unesi Z , Sajed A, Sharifzadeh G R. The Effects of Manual Pressure on the Injection Site on Vaccination Pain Among Infants: A Two-Group Clinical Trial. Mod Care J. 2019;16(4):e95705. doi: 10.5812/modernc.95705.

  BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Duygu GÖZEN, Ph.D

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 22, 2021
• Study Start: November 22, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 5, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

TU (1)