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.: PACTR202607483106796 Date of Registration: 14/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Brief Psychological Intervention on Preoperative Anxiety Among Adult Patients Undergoing Elective Surgeries in Northern Nigeria
Official scientific title Effect of Brief Psychological Intervention on Preoperative Anxiety Among Adult Patients Undergoing Elective Surgeries in Northern Nigerian Tertiary Hospital
Brief summary describing the background and objectives of the trial Background: Whole-person care, advocating for comprehensive psychological, social, and spiritual support to all patients, is integral to contemporary healthcare. Stressful life events, such as surgery, often trigger anxiety and lead to physical and psychological changes. Preoperative anxiety, characterised by concern, fear, tension, and unease, is prevalent among individuals undergoing surgery. High levels of preoperative anxiety may correlate with reduced patient satisfaction and adverse anaesthesia and surgical outcomes. Non-pharmacological approaches are increasingly preferred by patients for managing preoperative anxiety. In light of this, our study aimed to assess the impact of a brief psychological intervention on preoperative anxiety in patients undergoing elective procedures, with the goal of enhancing recovery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BPIPA Trial
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Psychosocial
Anticipated trial start date 02/05/2022
Actual trial start date 02/05/2022
Anticipated date of last follow up 22/08/2022
Actual Last follow-up date 22/08/2022
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants) 144
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care Preoperatively Preoperative care 72 Active-Treatment of Control Group
Experimental Group Brief psychological intervention Single session 5 to 25 minutes The intervention group received a brief structured psychological counselling session (5–25 minutes) based on cognitive behavioural therapy (CBT) principles. It had two main components: 1. Cognitive component The researcher explored patients’ emotions, thoughts, and concerns about surgery. Patients were given empathic support using the NURS technique (Name, Understand, Respect, Support). Misconceptions and unrealistic fears about surgery (e.g., fear of dying, losing body parts, or supernatural beliefs) were identified and corrected, while reassurance and emotional validation were provided. 2. Behavioural component Patients were taught simple anxiety-reduction coping strategies, including: Breathing exercises (“air”) to manage anxiety symptoms Saliva swallowing technique (“water”) to activate relaxation response Positive imagery (“fire”) to replace negative thoughts with pleasant memories and reduce rumination 72
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18 years and above who underwent elective surgeries and consented to participate. 1. Patients who were mentally disabled and may not easily comprehend the questionnaire 2. Patients with communication difficulties, such as the deaf and dumb, because of the difficulties in administering the questionnaire and the intervention to them 3. Pregnant women, because anxiety about pregnancy outcome may be a confounder and physiologic changes in pregnancy, may affect their vital signs 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 95 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 03/09/2021 Ethics committee of Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Zaaria road Kano 700101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postperative anxiety On the morning of operation day when patient is already in the theatre
Secondary Outcome Surgical outcome In the morning on the surgery day while patients are in the theatre
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AMINU KANO TEACHING HOSPITAL KANO ZARIA ROAD KANO 700101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ogunyele Tiri Titilope Zaria Road Kano 700101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aminu Kano Teaching Hospital Zaria Road Kano 700101 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Tanko Salihu Tanimu Zaria Road Kano 700101 Nigeria
Zainab Abdulkadir Zaria road Kano 700101 Nigeria
Abdulgafar Lekan Olawumi Zaria Road Kano 700101 Nigeria
Fatima M. Damagum Zaria Road Kano 700101 Nigeria
Abdullahi I. Haruna Zaria Road Kano 700101 Nigeria
Bukar Alhaji Grema Zaria Road Kano 700101 Nigeria
Aishatu Umar Idris Zaria Road Kano 700101 Nigeria
Hussaini Yusuf Magaji Zaria Road Kano 700101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tiri OGUNYELE ogunyee1431@gmail.com 08066467611 Zaria Road
City Postal code Country Position/Affiliation
Kano 700101 Nigeria Consultant Family Physician
Role Name Email Phone Street address
Scientific Enquiries Abdulgafar Olawumi abdulgafarolawumi@yahoo.com +2348035110923 Zaria Road
City Postal code Country Position/Affiliation
Kano 700101 Nigeria Consultant Family Physician at Aminu Kano Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Zainab Abdulkadir zmeena2003@gmail.com +2348035881488 Zaria Road
City Postal code Country Position/Affiliation
Kano 700101 Nigeria Consultant Family Physician at Aminu Kano Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) generated from this study, including de-identified baseline characteristics, intervention exposure, anxiety assessment scores (pre- and post-intervention), perioperative outcomes, and relevant covariates, will be made available upon reasonable request from qualified researchers. All shared data will be fully de-identified to ensure confidentiality and compliance with ethical standards. Access to the IPD will be granted for methodologically sound proposals aimed at achieving the objectives stated in the approved protocol. Requests should be directed to the principal investigator or corresponding author, and approval will be subject to institutional ethical clearance and data-sharing agreements. Clinical Study Report One year Access to the individual participant data (IPD) from this study will be granted only to qualified researchers who submit a scientifically sound and methodologically robust proposal relevant to the objectives of the study or a justified secondary analysis. All requests must be accompanied by evidence of ethical approval from a recognized Institutional Review Board or Ethics Committee before data can be released. Data will only be shared with investigators who demonstrate appropriate academic or professional qualifications and experience in research methodology or biostatistics. Prior to access, requesters will be required to sign a formal data-sharing agreement outlining conditions for data use, confidentiality obligations, and strict prohibition of attempts to re-identify participants. The data will be provided strictly for non-commercial purposes, including academic, clinical, or public health research only. Researchers must also comply with applicable data protection and ethical standards to ensure confidentiality and responsible use of the dataset. In addition, a clear dissemination plan, including intended publications or presentations, must be submitted, with agreement on appropriate authorship or acknowledgment where applicable. Final approval for data access remains subject to review and authorization by the principal investigator and the host institution.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/06/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/06/2026
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 Public title 04/07/2026 Public title was written in upper case before EFFECT OF BRIEF PSYCHOLOGICAL INTERVENTION ON PREOPERATIVE ANXIETY AMONG ADULT PATIENTS UNDERGOING ELECTIVE SURGERIES IN NORTHERN NIGERIA Effect of Brief Psychological Intervention on Preoperative Anxiety Among Adult Patients Undergoing Elective Surgeries in Northern Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 04/07/2026 Public title was written in upper case before EFFECT OF BRIEF PSYCHOLOGICAL INTERVENTION ON PREOPERATIVE ANXIETY AMONG ADULT PATIENTS UNDERGOING ELECTIVE SURGERIES IN NORTHERN NIGERIA Effect of Brief Psychological Intervention on Preoperative Anxiety Among Adult Patients Undergoing Elective Surgeries in Northern Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 04/07/2026 Official scientific title was written in upper case before EFFECT OF BRIEF PSYCHOLOGICAL INTERVENTION ON PREOPERATIVE ANXIETY AMONG ADULT PATIENTS UNDERGOING ELECTIVE SURGERIES IN NORTHERN NIGERIAN TERTIARY HOSPITAL Effect of Brief Psychological Intervention on Preoperative Anxiety Among Adult Patients Undergoing Elective Surgeries in Northern Nigerian Tertiary Hospital
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 04/07/2026 Official scientific title was written in upper case before EFFECT OF BRIEF PSYCHOLOGICAL INTERVENTION ON PREOPERATIVE ANXIETY AMONG ADULT PATIENTS UNDERGOING ELECTIVE SURGERIES IN NORTHERN NIGERIAN TERTIARY HOSPITAL Effect of Brief Psychological Intervention on Preoperative Anxiety Among Adult Patients Undergoing Elective Surgeries in Northern Nigerian Tertiary Hospital
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 04/07/2026 Sample size did not match 132 144
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 04/07/2026 Sample size did not match 132 144
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 04/07/2026 Initial ethics document upload was not clear TRUE, Ethics committee of Aminu Kano Teaching Hospital, Zaaria road, Kano, 700101, Nigeria, , 03 Sep 2021, +2347068297396, info@akth.org.ng, 41531_38834_4737.pdf TRUE, Ethics committee of Aminu Kano Teaching Hospital, Zaaria road, Kano, 700101, Nigeria, , 03 Sep 2021, +2347068297396, info@akth.org.ng, 41531_38834_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/07/2026 Funding source name was initially stated as "self" instead of specific name Self , Zaria Road, Kano, 700101, Nigeria, Self Funded, Ogunyele Tiri Titilope, Zaria Road, Kano, 700101, Nigeria, Self Funded,