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Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia

Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia in Children and Adolescents After Thoracic Surgeries: a Randomized Double Blind Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03488459
Enrollment
112
Registered
2018-04-05
Start date
2012-03-01
Completion date
2014-12-30
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Surgery, Thoracic

Keywords

anxiety, preoperative education, psychologist, thoracotomy, Ravitch procedure, postoperative pain

Brief summary

The aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.

Detailed description

The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.

Interventions

BEHAVIORALRoutine preoperative information from a nurse

Routine preoperative information from a nurse.

BEHAVIORALAdditional information support from a psychologist

Routine preoperative information from a nurse + additional information support from a psychologist.

Sponsors

National Institute for Tuberculosis and Lung Diseases, Poland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* thoracic surgery (lateral thoracotomy or Ravitch procedure), * the American Society of Anesthesiologists score 1 or 2.

Exclusion criteria

* presence of a mental disorder, * anticancer treatment, * preoperative pain, * problems with verbal communication , * lack of postoperative drainage of the chest.

Design outcomes

Primary

MeasureTime frameDescription
Change in anxiety intensity scoresday prior to surgery, postoperative day 2Anxiety was determined with a Polish version of the self-inventory, either for children between 9 and 14 years of age, i.e. State-Trait Anxiety Inventory for Children (STAI-C; range: 20-60 pts) or for adolescents, i.e. State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. In this study, the levels of anxiety were determined twice: one day prior to surgery (both trait and state anxiety) and 48 h after the procedure (only state anxiety). The results were expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, \>7 = high level of anxiety).

Secondary

MeasureTime frameDescription
Pain intensity scores at restpostoperative hours: 1, 2, 4, 11, 24, 48The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Pain intensity scores during deep breathingpostoperative hours: 1, 2, 4, 11, 24, 48The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Pain intensity scores during coughingpostoperative hours: 1, 2, 4, 11, 24, 48The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
Patient satisfactionpostoperative day 2Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026