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Completed

NCT Number: NCT03488459

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

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.

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Key information

Conditions

Pain, Postoperative Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery, Thoracic

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, 34-700, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine preoperative information from a nurse

Behavioral

Routine preoperative information from a nurse.

Additional information support from a psychologist

Behavioral

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

Primary outcomes

  1. Change in anxiety intensity scores

    Time frame: day prior to surgery, postoperative day 2

    Anxiety 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 outcomes

  1. Pain intensity scores at rest

    Time frame: postoperative hours: 1, 2, 4, 11, 24, 48

    The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.

  2. Pain intensity scores during deep breathing

    Time frame: postoperative hours: 1, 2, 4, 11, 24, 48

    The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.

  3. Pain intensity scores during coughing

    Time frame: postoperative hours: 1, 2, 4, 11, 24, 48

    The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.

  4. Patient satisfaction

    Time frame: postoperative day 2

    Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good

Sponsors and collaborators

Lead sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 5, 2018
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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