Effect of Pranic Healing on Cardiorespiratory Indices and Pain During Venipuncture in Children

NCT06571357 | Not Yet Recruiting DMC

• 1 other identifier: PVF2024CAM001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether Pranic healing, based on Rogers' therapeutic touch nursing theory, can reduce pain and improve cardiorespiratory indices during venipuncture in children. The main questions it aims to answer are: Does Pranic healing reduce the pain experienced by children during venipuncture? How does Pranic healing affect cardiorespiratory indices, such as heart rate, respiratory rate, and arterial oxygen saturation, during and after venipuncture? Researchers will compare the effects of Pranic healing to routine care (without Pranic healing) to determine its effectiveness. Participants will: Receive Pranic healing or routine care before, during, and after venipuncture Have their pain levels, heart rate, respiratory rate, and arterial oxygen saturation measured Be randomly assigned to either the intervention group (Pranic healing) or the control group (routine care) Have their pain and physiological responses monitored and recorded during the procedure

Conditions

Pain, Acute; Therapeutic Touch

Keywords

Phlebotomy; Pain Management; Therapeutic Touch; Nursing Theory

Outcome Measures

Primary Outcomes (1)

• Pain Levels During Venipuncture

  The primary outcome measure will assess changes in pain levels experienced by children during venipuncture. Pain will be evaluated using the Wong-Baker FACES Pain Rating Scale, which is a validated tool for measuring pain in pediatric patients. The Wong-Baker FACES Pain Rating Scale ranges from 0 to 10, with 0 indicating "no pain" and 10 indicating "the worst pain possible." Higher scores represent worse pain outcomes.

  Pain levels will be measured at three time points: 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.

Secondary Outcomes (3)

• Changes in Arterial Oxygen Saturation

  Arterial oxygen saturation will be recorded at 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.

• Changes in Respiratory Rate

  Respiratory rate will be measured 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.

• Changes in Pulse Rate

  Pulse rate will be recorded at 5 minutes before venipuncture, during venipuncture, and 5 minutes after venipuncture.

Study Arms (2)

Pranic Healing Intervention

EXPERIMENTAL

Participants in this group will receive the Pranic Healing intervention, based on Martha Rogers' Science of Unitary Human Beings, specifically focusing on the concept of "Nursing as Facilitation of Healing." The Pranic Healing intervention will follow the advanced protocol as conceptualized by Master Choa Kok Sui, including the following seven techniques: Sensitizing the hands Scanning the Aura Cleansing the Aura Increasing the receptivity Energizing with prana Stabilizing the projected prana Releasing The intervention will be applied in three stages: 5 minutes before, during, and 5 minutes after venipuncture.

Behavioral: Pranic Healing

routine care

NO INTERVENTION

Participants in this group will receive routine care without any Pranic Healing intervention.

Interventions

Pranic Healing BEHAVIORAL

The Pranic Healing intervention will be applied according to the advanced protocol by Master Choa Kok Sui, involving seven key techniques: sensitizing the hands, scanning the aura, cleansing the aura, increasing receptivity, energizing with prana, stabilizing the projected prana, and releasing. The intervention will take place in three stages: 5 minutes before, during, and 5 minutes after venipuncture.

Also known as: Touch therapy

Pranic Healing Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 12 years experiencing pain during venipuncture
• Willingness of the child and family to cooperate and participate in the research
• No specific mental disorder as reported by the parents
• Not having taken acetaminophen or any other painkillers the night before

You may not qualify if:

• Severe restlessness of the child
• Lack of consent from the mother to continue participating in the study

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University

Nicosia, KKTC (Turkish Republic of Northern Cyprus), 99138, Cyprus

Location

Related Publications (6)

• Bahrami P, Sheikhan E, Soulari ZS, Golchin M. The Effect of Gentle Touch on Cardiorespiratory Indices and Pain Behaviors Related to Venipuncture and Blood Sampling in Preterm Infants Under Intensive Care. Iran J Nurs Midwifery Res. 2023 Jun 21;28(3):273-279. doi: 10.4103/ijnmr.ijnmr_306_21. eCollection 2023 May-Jun.

  PMID: 37575506 BACKGROUND

• Nittur A, Pavan B, Ganapathy R, Dorai VK, Singhal S. Pranic Healing as a Complementary Therapy in Diabetic Foot Ulcer Management: A Randomised, Controlled, Double-Blind Trial. Glob Adv Integr Med Health. 2023 Oct 23;12:27536130231183429. doi: 10.1177/27536130231183429. eCollection 2023 Jan-Dec.

  PMID: 37881236 BACKGROUND

• Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 Oct 15.

  PMID: 31628067 BACKGROUND

• Matourypour P, Zare Z, Mehrzad V, Musarezaie A, Dehghan M, Vanaki Z. An investigation of the effects of therapeutic touch plan on acute chemotherapy-induced nausea in women with breast cancer in Isfahan, Iran, 2012-2013. J Educ Health Promot. 2015 Aug 6;4:61. doi: 10.4103/2277-9531.162380. eCollection 2015.

  PMID: 26430688 BACKGROUND

• Alp FY, Yucel SC. The Effect of Therapeutic Touch on the Comfort and Anxiety of Nursing Home Residents. J Relig Health. 2021 Jun;60(3):2037-2050. doi: 10.1007/s10943-020-01025-4.

  PMID: 32415423 BACKGROUND

• Gantt M, Orina JAT. Educate, Try, and Share: A Feasibility Study to Assess the Acceptance and Use of Reiki as an Adjunct Therapy for Chronic Pain in Military Health Care Facilities. Mil Med. 2020 Mar 2;185(3-4):394-400. doi: 10.1093/milmed/usz271.

  PMID: 31642490 BACKGROUND

Related Links

• Official site for Pranic Healing with information about techniques and training.
• Website for Near East University Faculty of Nursing, providing details about the institution and its research activities.

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Pouran Varvani Farahani, PhD

  PhD student in Pediatric Nursing, Near East University, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pouran Varvani Farahani, PhD

CONTACT

+90 392 671 1111; 20222948@std.neu.edu.tr

Pouran Varvani Farahani, PhD

CONTACT

+90 548 865 2523; pfarahani@ciu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To minimize biased information, we employed a double-blind approach. The data will be collected by the researcher, and the statistician will be unaware of the groups; data will be analysed as variables x1 and x2.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student in Pediatric Nursing, Near East University , Faculty of Nursing

Model Details: Participants in this clinical trial will be randomly assigned to one of two groups: an experimental group receiving Pranic Healing and a control group receiving standard care. Both groups will be observed in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)