ClinicalTrials.gg
CompletedNCT03488459Updated Apr 5, 2018

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

An interventional study of Routine preoperative information from a nurse and Additional information support from a psychologist in Pain, Postoperative and Surgery, Thoracic, sponsored by National Institute for Tuberculosis and Lung Diseases, Poland. Completed at 1 site in Poland. Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by National Institute for Tuberculosis and Lung Diseases, Poland · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Mar 2012, registered Mar 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
9 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 48 studies in Pain, Postoperative with a site in Poland — 8 open to participants now, 9 under way, none of them phase 3. Pain, Postoperative · Poland.

Enrollment
18th of 45
112 · median 104
Started
2012
with 1 other
No phase
20 of 48
5 open now
Registered
23rd of 48
by date
Lead sponsor
3 of 48
National Institute for Tuberculosis and Lung Diseases, Poland

Among the 48 studies in Pain, Postoperative with a site in Poland, this one is the 18th largest by enrollment of the 45 interventional ones that give a count, is one of 2 that started in 2012, is one of 20 with no phase, and was the 23rd registered.

Pain, Postoperative

5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

8 of the 48 studies in Pain, Postoperative with a site in Poland are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →

Who these studies take

Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 9 Years to 18 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Pain, Postoperative
  • Surgery, Thoracic

Keywords

  • anxiety
  • preoperative education
  • psychologist
  • thoracotomy
  • Ravitch procedure
  • postoperative pain
04

Who can participate

Ages eligible
9 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • thoracic surgery (lateral thoracotomy or Ravitch procedure),
  • the score 1 or 2.

Exclusion criteria

Exclusion Criteria:

  • presence of a mental disorder,
  • anticancer treatment,
  • preoperative pain,
  • problems with verbal communication ,
  • lack of postoperative drainage of the chest.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
112 participants (actual)

Study arms

  • Other
    Routine preoperative information from a nurse

    Behavioral: Routine preoperative information from a nurse

  • Experimental
    Additional information support from a psychologist

    Behavioral: Additional information support from a psychologist

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.

06

What researchers measure

Primary outcomes

  1. Change in anxiety intensity scores

    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).

    Time frame: day prior to surgery, postoperative day 2

Secondary outcomes

  1. Pain intensity scores at rest

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

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

  2. Pain intensity scores during deep breathing

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

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

  3. Pain intensity scores during coughing

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

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

  4. Patient satisfaction

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

    Time frame: postoperative day 2

07

Study locations

1 site
  • Institute for Tuberculosis and Lung Diseases, Pediatric Division
    Rabka-Zdrój, Małopolska 34-700, Poland
08

References and documents

Publications

  • Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19. PubMed 23865442 ↗
  • Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100. PubMed 23289773 ↗
  • Fincher W, Shaw J, Ramelet AS. The effectiveness of a standardised preoperative preparation in reducing child and parent anxiety: a single-blind randomised controlled trial. J Clin Nurs. 2012 Apr;21(7-8):946-55. doi: 10.1111/j.1365-2702.2011.03973.x. Epub 2012 Feb 3. PubMed 22300416 ↗
  • Tomaszek L, Cepuch G, Fenikowski D. Influence of preoperative information support on anxiety, pain and satisfaction with postoperative analgesia in children and adolescents after thoracic surgery: A randomized double blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Jun;163(2):172-178. doi: 10.5507/bp.2018.060. Epub 2018 Oct 5. PubMed 30305761 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2012 to primary completion in Dec 2014, 33 months.

Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 33 months is above that.

Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2018
First posted
Apr 5, 2018
StartActual
Mar 1, 2012
Primary completionActual
Dec 30, 2014
CompletionActual
Dec 30, 2014
Last update
Apr 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03488459
Lead sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Mar 1, 2012
Primary completion
Dec 30, 2014
Completion
Dec 30, 2014
Last update
Apr 5, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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