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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609528410413 Date of Registration: 01/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of parental presence on children’s anxiety level during induction of anaesthesia
Official scientific title The effect of parental presence on children’s anxiety level during induction of anaesthesia at the University Teaching Hospital, Lusaka.
Brief summary describing the background and objectives of the trial Preoperative anxiety occurs in all age groups, but is greater in the paediatric population. Paediatric anesthesia induction is a pivotal phase in the perioperative experience that often evokes anxiety and distress. Studies reveal high prevalence levels of anxiety, 50-75% among children undergoing anaethesia, in both global and regional settings, despite differences in the availability of resources. Preoperative anxiety increases the time for induction of aneasthesia and overall turnover time. In addition, physiological effects such as increased heart rate and blood pressure may lead to increased anaesthetic and analgesic requirements, and emergence delirium postoperatively. Long-term effects include sleep disorders, enuresis, apathy, and separation anxiety which can cause parental dissatisfaction. One factor that has been explored in mitigating this anxiety is the presence of parents in the preoperative setting. Research has shown that the presence of parents during medical procedures can have a calming effect on children. This can potentially reduce anxiety and enhance their ability to cope with the stress associated with the induction of anaesthesia. This study aims to explore the presence of parents in the preoperative setting in mitigating anxiety. Specific objectives: 1. To examine the relationship between parental presence and preoperative anxiety levels in children. 2. To identify risk factors for the development of preoperative anxiety in children. 3. To estimate the effect of parental presence on children's anxiety during induction of anaesthesia, while controlling for other baseline characteristics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2024
Actual trial start date 07/04/2025
Anticipated date of last follow up 01/07/2025
Actual Last follow-up date 04/08/2025
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 94
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No Parental presence At induction of anaesthesia No parental presence during the induction of anaesthesia in children 47 Uncontrolled
Experimental Group Parental presence At induction of anaesthesia Parental presence during the induction of anaesthesia in children 47
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants aged 2 – 10 ASA 1 & 2 Participants undergoing elective minor procedures like inguinal or umbilical hernia repair, undescended testes, and male circumcision. Paediatric patients whose parents will consent to participate in the study Participants undergoing emergency surgical procedures ASA 3 & 4 Participants with previous anaesthesia or surgical exposure. Participants with chronic illness or neuro-developmental delay Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 10 Year(s) Both
Participants aged 2 – 10 ASA 1 & 2 Participants undergoing elective minor procedures like inguinal or umbilical hernia repair, undescended testes, and male circumcision. Paediatric patients whose parents will consent to participate in the study Participants undergoing emergency surgical procedures ASA 3 & 4 Participants with previous anaesthesia or surgical exposure. Participants with chronic illness or neuro-developmental delay Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 10 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 26/11/2024 University of Zambia Biomedical Research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
Great east road Lusaka 32379 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anxiety in child before induction in waiting area and at induction of anaesthesia
Secondary Outcome parental anxiety in waiting area, after induction of anaesthesia in treatment group
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Teaching Hospital Adult nationalist road lusaka Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Kotutu Mulenga Nationalist road University Teaching Hospitals Lusaka Zambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Hazel Mumpasha Nationalist Road- University Teaching Hospitals Lusaka Zambia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kotutu Lombe Mulenga kotutulombe@gmail.com +260974332205 Nationalist road- University Teaching Hospitals
City Postal code Country Position/Affiliation
Lusaka Zambia Medical Doctor Registrar Anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Hazel Mumpasha hazelsonkwe5@gmail.com +260969239620 University Teaching Hospitals Nationalist Road
City Postal code Country Position/Affiliation
Lusaka Zambia Consultant Anaesthesia
Role Name Email Phone Street address
Public Enquiries Bristol Ntebeka ntebekabristoljr@gmail.com +260962261384 University Teaching Hospital Nationalist Road
City Postal code Country Position/Affiliation
Lusaka Zambia Epidemiologist Research Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available, including all the data collected during the trail after deidentification. Access will be restricted to the investigator and the ethical bodies. This will include study protocols, consent, questionnaires and result analysis. Study Protocol No end date Controlled access of data
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 26/08/2026 Trail is completed 07 Apr 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 26/08/2026 Trail is completed 04 Aug 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 16/02/2026 Recalculated sample size 81 90
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 26/08/2026 To account for participants dropped out 94
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/08/2026 Trail was completed Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/07/2026 The intervention name was the same as the control group Experimental Group, Parental presence, , At induction of anaesthesia, Parental presence during the induction of anaesthesia in children, 45,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/07/2026 The intervention name was the same as intervention group Control Group, Parental presence, , At induction of anaesthesia, no parental presence during the induction of anaesthesia in children, 45, Uncontrolled Control Group, No Parental presence, , At induction of anaesthesia, No parental presence during the induction of anaesthesia in children, 45, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 26/08/2026 The intervention name was the same as intervention group Control Group, No Parental presence, , At induction of anaesthesia, No parental presence during the induction of anaesthesia in children, 45, Uncontrolled Control Group, No Parental presence, , At induction of anaesthesia, No parental presence during the induction of anaesthesia in children, 47, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 26/08/2026 Trail completed and total number of participants was 94 Experimental Group, Parental presence, , At induction of anaesthesia, Parental presence during the induction of anaesthesia in children, 45, Experimental Group, Parental presence, , At induction of anaesthesia, Parental presence during the induction of anaesthesia in children, 47,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/02/2026 correct email address inserted TRUE, University of Zambia Biomedical Research Ethics Comittee, Great east road, Lusaka, 32379, Zambia, , 26 Nov 2024, +260211290258, drgs@unza.zm, 30662_33176_4737.pdf TRUE, University of Zambia Biomedical Research Ethics Comittee, Great east road, Lusaka, 32379, Zambia, , 26 Nov 2024, +260211290258, unzarec@unza.zm, 30662_33176_4737.pdf