Pain, PostoperativeNCT03488459
Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia
A study testing Routine preoperative information from a nurse and Additional information support from a psychologist in people with Pain, Postoperative and Surgery, Thoracic, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
Trial 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 more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Pain, Postoperative, Surgery, Thoracic
- What is being tested?
- Routine preoperative information from a nurse and Additional information support from a psychologist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2012to 30 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- thoracic surgery (lateral thoracotomy or Ravitch procedure),
- the American Society of Anesthesiologists score 1 or 2.
Who cannot join
- presence of a mental disorder,
- anticancer treatment,
- preoperative pain,
- problems with verbal communication ,
- lack of postoperative drainage of the chest.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, 34-700
About this study
Official 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
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.
- Conditions
- Pain, Postoperative, Surgery, Thoracic
- Being tested
- Routine preoperative information from a nurse, Additional information support from a psychologist
- Keywords
- anxiety, preoperative education, psychologist, thoracotomy, Ravitch procedure, postoperative pain
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine preoperative information from a nurseBehavioural
Routine preoperative information from a nurse.
Additional information support from a psychologistBehavioural
Routine preoperative information from a nurse + additional information support from a psychologist.
| Study group | Role | What they receive |
|---|---|---|
| Routine preoperative information from a nurse | Other | Not described Receives: Behavioral: Routine preoperative information from a nurse |
| Additional information support from a psychologist | Experimental | Not described Receives: Behavioral: Additional information support from a psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day prior to surgery, postoperative day 2
Secondary outcomes (4)
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.
Measured: postoperative hours: 1, 2, 4, 11, 24, 48
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.
Measured: postoperative hours: 1, 2, 4, 11, 24, 48
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.
Measured: postoperative hours: 1, 2, 4, 11, 24, 48
Patient satisfaction
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Mar 2012
- Primary completion30 Dec 2014
- Study completion30 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488459
- Sponsor's protocol ID
- 10.5
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 23865442Cuzzocrea 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 23289773Fincher 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 22300416Tomaszek 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03488459
- Acronym / sponsor ID
- 10.5
- Conditions
- Pain, Postoperative, Surgery, Thoracic
- Keywords
- anxiety, preoperative education, psychologist, thoracotomy, Ravitch procedure, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine preoperative information from a nurse | Other | Behavioral: Routine preoperative information from a nurse |
| Additional information support from a psychologist | Experimental | Behavioral: Additional information support from a psychologist |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- thoracic surgery (lateral thoracotomy or Ravitch procedure),
- the American Society of Anesthesiologists score 1 or 2.
Key exclusion criteria (5 listed)
- presence of a mental disorder,
- anticancer treatment,
- preoperative pain,
- problems with verbal communication ,
- lack of postoperative drainage of the chest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine preoperative information from a nurseRoutine preoperative information from a nurse. | Behavioural | Routine preoperative information from a nurse |
| Additional information support from a psychologistRoutine preoperative information from a nurse + additional information support from a psychologist. | Behavioural | Additional information support from a psychologist |
Primary outcome
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).
4 secondary outcomes
Pain intensity scores at rest
Time frame: postoperative hours: 1, 2, 4, 11, 24, 48
Pain intensity scores during deep breathing
Time frame: postoperative hours: 1, 2, 4, 11, 24, 48
Pain intensity scores during coughing
Time frame: postoperative hours: 1, 2, 4, 11, 24, 48
Patient satisfaction
Time frame: postoperative day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 23865442Chieng 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.
- Background: PubMed 23289773Cuzzocrea 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.
- Background: PubMed 22300416Fincher 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.
- Derived from this study: PubMed 30305761Tomaszek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine preoperative information from a nurse and Additional information support from a psychologist in people with Pain, Postoperative and Surgery, Thoracic, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety intensity scores (time frame: day prior to surgery, postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488459, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.