Effect of Pranic Healing on Cardiorespiratory Indices and Pain During Venipuncture in Children
NCT ID: NCT06571357
Last Updated: 2024-08-27
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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NOT_YET_RECRUITING
NA
46 participants
INTERVENTIONAL
2024-10-01
2024-12-01
Brief Summary
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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
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Detailed Description
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Study Subjects: Sample Size: 46 school-aged children, aged 6 to 12 years. Sampling Method:Convenience sampling followed by random block sampling. Groups: Experimental group (Pranic healing) and control group.
Sample size determination:
The statistical population of this research includes school-aged children admitted to one hospital in Northern Cyprus.
After obtaining consent, the children were randomly will be divided into the experimental and control groups. Then, a control and experimental group of 23 people will be formed by random block sampling method. In this method, blocks are formed based on the variables in question, and half of the intervention people and half of the control people are included in each block, the main goal in this method is to balance the number of participants in each of the groups. The four block randomization method will be used and the patients will be placed in experimental group groups (A) and control group (B), so that first 12 blocks of four and one block of two were prepared as follows: AABB, ABAB , ABBA, BBAA, BABA, BAAB, ABAB, AABB, BBAA, BAAB, BABA, ABBA, AB And then people will be assigned to two groups based on the list prepared in terms of A and B; This work is continuously repeated until the sample size is completed.
The samples of this research according to the sample size formula considering the 20% drop, there are 23 school-age children in each group. That have criteria for entering the research. The samples are divided into control and intervention groups using convenience sampling method. 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.
Based on the study (Dehghani et al., 2019) and the mean comparison formula, the first type error level is 0.05, the power of the test is 80%, the sample size in each group is 19 people, which is 23 people in each group considering 20% dropout.
Tools of data collection:
To address the goals of the research, the data will be collected using questionnaires, Pain intensity scale, flow sheet, the intensive care monitor and a pulse oximeter.
A) The questionnaire for collecting demographic data on children and parents will be one of the tools utilized.
B) Pain intensity scale: The instrument used to measure pain will be Wong and Baker Facial Pain Scale. This scale is used in children aged 3 and older to rate pain severity (Yıldırım \& Gerçeker, 2023). The child was asked to choose the face expressing their pain. It was presented in 1988 and 1996 by Wong and Baker and consists of six cartoon figures with experiences of no pain to the most severe pain that is crying. (0 to 5 or 0 to 10) (Hockenberry, 2019b) In this research, Wong and Baker Facial Pain Scale will be used in Turkish. )Appendix 2 (Wong and Baker Facial Pain Scale has been widely used and its validity and reliability have been proven in acute pain (Kamki et al., 2022) . Seval conducted a project to validate the Turkish version this tool in 2020, obtaining the internal consistency coefficient was 0.851 and the correlations was r =0.79 (Seval, 2020).
C) Children's pain assessment and measurement of cardiorespiratory indices, recording flow sheet: It consists of seven items. These questionnaires will be completed through observation by researcher in both groups.
D) The respiration rate of the child, pulse rate and arterial oxygen saturation will be measured using a pulse oximeter and intensive care monitor. Pulse oximetry will be valid, and to ensure the reliability of research tool, only one pediatric pulse oximeter will be used for all participants. Equivalent reliability method will be also used to evaluate the reliability of the monitor; its accuracy will be compared with another device each time before the intervention.
Intervention: Experimental Group: Pranic healing will be administered 5 minutes before, during, and 5 minutes after venipuncture. Control Group: Will receive routine care without additional intervention.
Implementation phase:
The present study is a clinical trial study. The research population is all children aged 6 to 12 admitted with a diagnosis in the children's department of Near East Hospital in Northern Cyprus. 46 samples of eligible children whose mothers are willing to participate in the study will be selected. The samples will be divided into two equal groups by random and Convenience sampling method. After explaining the purpose and how to do the work, written informed consent will be obtained from the mothers. The samples will be divided into Pranic healing therapy and control groups.
Demographic information questionnaire will be completed for each child. To perform the intervention, Pranic healing will be performed 5 minutes before and during the venipuncture and 5 minutes after in the experimental group. The researcher who will perform Pranic therapy is trained by a Pranic therapist. She has a certificate from World Pranic Healing Foundation (Appendix 4. ( In this study interventions, the intervention will be conducted in the privacy of the participant's room. The participants will be guided. They will lie on their backs on their hospital beds for the treatment. Prior to the treatment, they will be instructed to relax as fully as possible and a brief explanation of Pranic healing procedures will be given by an informative brochure and a CD containing educational videos pertaining to Pranic healing. Martha Rogers' Science of Unitary Human Beings, the concept of "Nursing as Facilitation of Healing" is central to understanding the role of nurses in promoting health and well-being. In this study, we will use Roger's concept of "nursing as a facilitator of healing" from Pranic Healing method as a facilitator of the healing process. The Pranic advanced protocol will be applied as conceptualized by Master Choa Kok Sui (Sui CK, 2004). Pranic healing protocol applied in this study will be based on the following seven techniques: 1. sensitizing the hands, 2. scanning the Aura, 3. cleansing the aura, 4. increasing the receptivity, 5. energizing with prana, 6. Stabilizing the projected prana and 7. Releasing (Sui choa kok, 2018) (Jois et al., 2018).
For the sampling, after ensuring that children will be ready for sampling, the nurse will be performed venipuncture then, the intervention will be performed in three stages (5 minutes before, during, and 5 minutes after venipuncture ). In the control group, no intervention will be performed, and children only received routine care. Children pain, the arterial oxygen saturation, the number of breaths and pulse rate will be measured and recorded. The venipuncture will be done by a skilled nurse. In order to ensure the consistency of the conditions, the intervention will be scheduled for shifts in which the nurse will be on duty in the ward.
Ethic committee:
The study's aim and methodology will be explained to the participants. Participants will be given the assurance that they can leave the study at any moment without incurring any fees. Finally, the parent and children who voluntarily stated their involvement in the study will provide written informed consent. The study was carried out in accordance with the Declaration of Helsinki's principles (Declaration H, 1964). Moreover, 1. After gaining consent (the experimental and control groups' signed written consent), the participants were informed of the research's goals and placed into groups as project samples. 2. The project units received guarantees that the data is private and won't have any unfavourable effects. 3. It was assured to the project units that doing this yoga has no negative effects. 4. The goals and benefits of the initiative were presented to the authorities, who will also have access to the results upon request. 5. If they agreed, the control group received super brain yoga training. Every participant gave written agreement as a volunteer and acknowledged that they were free to leave the study at any moment. The written consents to participate in the project were received.
Statistical analysis:
The data is entered into spss26 software. Descriptive statistics are performed for quantitative changes with size and quality deviation, and for qualitative changes with frequency and percentage. Chi-square test or Fisher's exact test is used in inferential statistics for several qualities. For quantitative changes, after checking the hypothesis of normality with the Kolmogorov Smirnov test, independent t-tests and repeated measures analysis of variance (ANOVA) or their non-parametric equivalent Mann-Whitney and Wilcoxon tests will be used. A significance level of less than 0.05 is considered for all statistical tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Pranic Healing Intervention
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.
Pranic Healing
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.
routine care
Participants in this group will receive routine care without any Pranic Healing intervention.
No interventions assigned to this group
Interventions
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Pranic Healing
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Lack of consent from the mother to continue participating in the study
6 Years
12 Years
ALL
No
Sponsors
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Near East University, Turkey
OTHER
Responsible Party
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Pouran Varvani Farahani
PhD student in Pediatric Nursing, Near East University , Faculty of Nursing
Principal Investigators
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Pouran Varvani Farahani, PhD
Role: PRINCIPAL_INVESTIGATOR
PhD student in Pediatric Nursing, Near East University, Faculty of Nursing
Locations
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Near East University
Nicosia, KKTC (Turkish Republic of Northern Cyprus), Cyprus
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Study Documents
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Document Type: Study Protocol
The study protocol will be available through the Near East University research portal. For access, please contact the central research office at Near East University
View DocumentRelated Links
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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.
Other Identifiers
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PVF2024CAM001
Identifier Type: -
Identifier Source: org_study_id
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