Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407479098909 Date of Approval: 15/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Modified Valsalva Maneuver versus Standard Valsalva Maneuver on Clinical Outcomes and Satisfaction of Children Suffering from Paroxysmal Supraventricular Tachycardia
Official scientific title Efficacy of Modified Valsalva Maneuver versus Standard Valsalva Maneuver on Clinical Outcomes and Satisfaction of Children Suffering from Paroxysmal Supraventricular Tachycardia
Brief summary describing the background and objectives of the trial Paroxysmal supraventricular tachycardia (PSVT) is the most frequent form of sustained tachycardia in childhood. In stable patients, the initial management should consist of vagal maneuvers, for ending the tachycardia in cases involving the atrioventricular node in the conduction pathway. In children and adolescents, this is mainly achieved through the Valsalva maneuver. Valsalva maneuver (VM) is a simple and easy method to return to sinus rhythm by stimulating the Vagus nerve. The attack of SVT is a major cause of arrhythmias for patients in the emergency department (ED), and it can cause fatigue, dizziness, headache, chest distress, dyspnea, and even endanger the safety of patients in some cases Design: A quasi-experimental research design will be used. Setting: It will be conducted at emergency department at Tanta University Hospitals. Aim of the study: to evaluate the efficacy of Modified Valsalva Maneuver versus Standard Valsalva Maneuver on Clinical Outcomes and Satisfaction of Children Suffering from Paroxysmal Supraventricular Tachycardia
Type of trial RCT
Acronym (If the trial has an acronym then please provide) preparation
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Paraoxsmal supraventricular tachycardia
Purpose of the trial Supportive care
Anticipated trial start date 06/06/2024
Actual trial start date 01/07/2024
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date 31/12/2024
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group routine care 3 times 1 minute the standard VM group were placed in a semi-recumbent position at an angle of 45° to the bed surface. The nurse guided participants to close the glottis after completing a normal inhalation in a tidal volume state. Participants closed the glottis and exhaled vigorously for 10-15 s. Then, the participants relaxed and resumed normal breathing before maintaining this posture for 1 min. 30 Placebo
Experimental Group modified valsalva manuver 3 times 1 minute the modified VM group were placed in a semi-recumbent position or sitting position at an angle of 45° to 90° to the bed surface for completion of a normal inhalation in a tidal volume state. The patients were then asked to blow into 10 mL syringes to move the plunger to achieve the recommended intrathoracic pressure of 40 mmHg. The state of exertion was maintained for 15 s, and the signs of acceptable motion included jugular vein filling, increased abdominal muscle tension, and flushing. Then, the patient was suddenly placed in the supine position and his/her legs were raised at a 45° angle, which was maintained for 15 s by the researcher. The participants then returned to the semi-recumbent position for 45 s. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with stable supraventricular tachycardia. Age ranged from 7 to 17 years. Both sexes. - Children with unstable Supraventricular tachycardia. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 7 Year(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/06/2024 Scientific Research Ethical Commitee
Ethics Committee Address
Street address City Postal code Country
Elgeish street tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physiological indices: Blood pressure, heart rate, respiratory rate and O2 levels and ECG. The visual analogue scale (VAS) for dyspnea The Short Assessment of Patient Satisfaction before and after care
Secondary Outcome The Short Assessment of Patient Satisfaction after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgeish street tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
samar eldesoky mohamed ads Elgeish street tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of nursing of tanta university Elgeish street tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Sahar Elkhder sahar.abdelgawad@nursing.tanta.edu.eg 00201142306018 Elgalaa street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Vice dean of Postgraduate and Researches
Role Name Email Phone Street address
Principal Investigator Seham El halafawy seham.elhalafawi@nursing.tanta.edu.eg 01007878554 Kafr Elzayat
City Postal code Country Position/Affiliation
Elgarbia 31511 Egypt Lecturer of Pediatric Nursing
Role Name Email Phone Street address
Public Enquiries Sahar Melika sahar_maleeka@tanta.nursing.edu.eg 01553238428 Elbahr street
City Postal code Country Position/Affiliation
tanta 68500 Egypt Lecturer of Pediatric Nursing
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trail, after deidentification Informed Consent Form,Study Protocol immediately following publication. No end date controlled access after approval of the authors
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information