Intervention to reduce stressful emotions in children scheduled to undergo surgery

ISRCTN	ISRCTN16198907
DOI	https://doi.org/10.1186/ISRCTN16198907
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	456
Sponsor	University General Hospital Attikon
Funder	Investigator initiated and funded

Submission date: 29/12/2022
Registration date: 30/01/2023
Last edited: 30/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Children who undergo surgical and endoscopic procedures display high levels of stress, and various means are applied to reduce anxiety. Salivary cortisol is often used as a valid biomarker of stress. The aim of this study is to determine whether the application of the Theory of Planned Behavior (TPB) as an intervention to parents could ultimately reduce stress levels in children who undergo surgical or endoscopic procedures, as measured through salivary cortisol levels, and whether parents would be willing to allow their children to participate in the diagnostic procedure of saliva collection.

Who can participate?
Children scheduled to undergo surgical and endoscopic procedures and their parents

What does the study involve?
Participants were divided into two groups: Explained and Unexplained. The Explained Group comprised children and one of their parents who, after completion of the questionnaire, were provided with information concerning the entire procedure. After this training, parents communicated the given information to their children. The second, the Unexplained Group, included children and one of their parents who after completing the questionnaire received no explanation related to the surgical or endoscopic procedure. Three saliva samples were collected during the following hours: 7:00 a.m. – 9:00 a.m. in the clinic room; 9:00 a.m. – 12:00 a.m. just before anesthesia administration; and 5:00 p.m. – 7:00 p.m.

What are the possible benefits and risks of participating?
Providing proper education and information for parents may have a positive effect on reducing children’s stress levels. Changing parental attitudes towards saliva collection plays the most important role, since a positive attitude can influence intention and ultimately participation in these procedures.

Where is the study run from?
University General Hospital Attikon (Greece)

When is the study starting and how long is it expected to run for?
January 2020 to January 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Nikolaos Zavras, nzavras@med.uoa.gr

Contact information

Prof Nikolaos Zavras
Principal investigator

1 Rimini str
Haidari
12462
Greece

ORCID ID	0000-0003-2546-4533
Phone	+30 (0)2105832373
Email	nzavras@med.uoa.gr

Study information

Primary study design	Observational
Study design	Prospective observational case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	The planned behavioral theory as an interventional tool to reduce stress in children undergoing surgical and endoscopic procedures as proved by salivary cortisol
Study acronym	PBT
Study objectives	To investigate the Planned Behavioral Theory as a tool to reduce stress levels in children who are undergoing surgical or endoscopic procedures, as measured through salivary cortisol levels, and whether parents would be willing to allow their children to participate in the diagnostic procedure of saliva collection
Ethics approval(s)	Approved 18/02/2020, Scientific Board of the Attiko University General Hospital (1 Rimini Str, Haidari, Athens, 12462, Greece; +30 (0)2105831000; politis@attikonhospital.gr), ref: ΕΒΔ753/12-12-2019
Health condition(s) or problem(s) studied	Stress reduction
Intervention	Consecutive children scheduled to undergo a surgical operation or endoscopy (gastroscopy or coloscopy, or both) were recruited. The patients were divided into two groups: Explained and Unexplained. The Explained Group comprised children and one of their parents who, after completion of the questionnaire, were provided with information concerning the entire procedure. After this training, parents communicated the given information to their children. The second, the Unexplained Group, included children and one of their parents who after completing the questionnaire received no explanation related to the surgical or endoscopic procedure. Three saliva samples were collected during the following hours: 7:00 a.m. – 9:00 a.m. in the clinic room; 9:00 a.m. – 12:00 a.m. just before anesthesia administration; and 5:00 p.m. – 7:00 p.m.
Intervention type	Behavioural
Primary outcome measure(s)	Salivary cortisol concentration in children measured using commercially available kits. Three saliva samples were collected during the following hours: 7:00 a.m. – 9:00 a.m. in the clinic room; 9:00 a.m. – 12:00 a.m. just before anesthesia administration; and 5:00 p.m. – 7:00 p.m.
Key secondary outcome measure(s)	Parental intention measured at 7.00-9.00 am (on admission) using 18 items divided into the following sub-scales: 1. Intention: the assessment of parental intention towards saliva collection included three items based on a seven-point Likert scale, with 1 as unlikely and 7 likely. Higher mean scores indicated parental intention 2. Attitude: this subscale concerns parental attitudes towards saliva collection with eight items, four of which focus on salivary biomarkers, and four on whether saliva sampling affects general health. All items were based on a seven-point Likert scale. 1: unpleasant/stressful. ...7: pleasant/significant 3. Subjective norms: included items regarding parental perception of subjective norms, which regard agreement or disagreement with the advice and prescriptive norms about saliva collection 4. Perceived behavioural control: Three items assessed parental perception regarding their ability to control saliva collection. More specifically, they evaluated perceived behavioural control as self-efficacy assessing the extent that adults perceive themselves as capable of showing behaviour, as graded on a seven-point Likert scale, of how at ease they felt regarding their children's participation in the collection of saliva. The answers ranged from 1: extremely difficult to 7: extremely high sense of control
Completion date	01/01/2022

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key inclusion criteria	1. Children scheduled to undergo surgical and endoscopic procedures and their parents 2. Ability to understand and participate in the research procedures
Key exclusion criteria	1. Children with a history of previous surgery or endoscopy, liver, renal, cardiac, pulmonary, neurological, and psychological diseases 2. Children who received steroids
Date of first enrolment	01/03/2020
Date of final enrolment	01/01/2022

Locations

Countries of recruitment

Greece

Study participating centre

University General Hospital Attikon

1 Rimini Str
Haidari
12462
Greece

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated and/or analysed during the current study are/will be available upon request from Zavras Nikolaos (nzavras@med.uoa.gr). Type of data: all data gathered during the processes of the study Dates of availability: Data will be available upon request within a reasonable timeframe Consent was obtained from all participants No ethical or legal restrictions arose

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/01/2023: Trial's existence confirmed by the Scientific Board of the Attiko University General Hospital.