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PainNCT02563587

Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

A study testing Laughter therapy, Accompaniment without causing the laughter of children. and Conventional treatment in people with Pain, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of laughter therapy in children to improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital stay. Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Pain
What is being tested?
Laughter therapy, Accompaniment without causing the laughter of children. and Conventional treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
1 siteMexico
Study dates
Sep 2015to Jan 2018
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 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Pediatric patients between 6 and 14
  • I hospitalized with uncomplicated surgical procedure
  • Minimum period of hospitalization of 48 hours
  • Patients with informed consent letter signed by parents or guardians
  • In patients older than 10 years, a letter of agreement

Who cannot join

  • Endocrinopathies carriers, cancer, abnormalities of central nervous system immune disorders patients.
  • Patients treated with both topical and systemic steroids

Trial locations and contacts

1 site in 1 country.

Magda Ruth Pérez Cervantes, Pediatrician contact

(52)5550371200 ext. 5423

dagmacancer@yahoo.com

Mexico1 site, 1 recruiting

  • Hospital General Naval de Alta Especialidad

    Mexico City, Mexico City, 04480

    Magda Ruth Pérez Cervantes, Pediatrician, (52)5550371200 ext. 5423, dagmacancer@yahoo.com

    Recruiting

Other trials in Mexico

About this study

Official title: Efficacy of the Spontaneous Laughter on Postoperative Pain and Anxiety in Children. A Randomized Controlled Trial

The purpose of this study is to determine the efficacy of laughter therapy in children to improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital stay.

Read the detailed description

The therapeutic efficacy of laughter is supported in several research which have shown to have preventive and therapeutic effects that contribute to a better quality of life. In addition, laughter can optimize strategies to increase pain tolerance and combat stress, reducing the negative impact such as increased blood pressure, decreases simultaneously perfusion of organs not needed for the motor function, increased metabolism rates cell with increased serum cortisol and increased risk of infections. Nevertheless the upswing in research on these effects, there is still a necessity to have evidence-based medicine as most of the available studies are limited by various problems such as lack of objectivity in the assessment and measurement, distinction between laughter and mood, establishment dosing therapies (frequency and time).

The aim of our study is to determine the efficacy of spontaneous laughter in children to improve postoperative pain, anxiety and length of hospital stay.

Methods: A controlled, randomized, open label trial with an experimental group exposed to the conventional pain treatment with laughter therapy; 2 control group, a group with accompaniment without causing the laughter of children to control the effect of a companion instead of the clown and a conventional treatment group to contrast with experimental group.

Conditions
Pain
Being tested
Laughter therapy, Accompaniment without causing the laughter of children., Conventional treatment
Keywords
Laughter, children, postoperative, pain, anxiety, cortisol
Medical subject headings
Pain, Laughter, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laughter therapyOther

    Also called Group LT-CT

    Laughter therapy sessions will begin as soon as / after that the complete anesthesia recovery, then we could start with two interventions, each of them in morning and during the afternoon will be held until their discharge lasting 30 minutes per each one, these sessions will be held in the service pediatric hospital by trained personnel in laughter therapy, which will be implemented through hospital clowns.

  • Accompaniment without causing the laughter of children.Other

    Also called Group AW-CT

    The interventions will be carried out by means of reading stories and own stories for the age. These sessions will begin subsequent to the full recovery of the anesthesia, and then two interventions per day, in the morning and evening, with duration of 30 minutes, until the time of his discharge, these sessions will take place in the service of Hospital pediatrics by the resident in charge.

  • Conventional treatmentDrug

    Also called Group CT

    Conventional treatment involves handling analgesic with non-steroidal anti-inflammatory drugs (paracetaol, metamizol and ketorolac) as prescribed by the doctor surgeon treating, which starts immediately in the postoperative period.

Study groups in NCT02563587
Study groupRoleWhat they receive
Group LT-CTExperimentalLaughter therapy with conventional treatment
Receives: Other: Laughter therapy
Group AW-CTPlacebo comparatorAccompaniment without causing the laughter of children more conventional treatment
Receives: Other: Accompaniment without causing the laughter of children.
Group CTSham comparatorConventional treatment only
Receives: Drug: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain level

    Pain level measurement at 48 hours determined by the visual analogue scale (Range: 0-10 cm)

    Measured: 48 hours after surgery

Secondary outcomes (8)

  1. Postoperative anxiety level

    Postoperative anxiety level determined by STAIC (State Trait Anxiety Inventory Children) (Range: 10-40 points)

    Measured: 48 hours after surgery

  2. Postoperative urinary cortisol level

    Postoperative stress level determined by urinary cortisol (μg/dl)

    Measured: 48 hours after surgery

  3. Postoperative heart rate

    Postoperative heart rate (beat per minute)

    Measured: 48 hours after surgery

  4. Postoperative respiratory rates

    Postoperative breathing frequency (breath per minute)

    Measured: 48 hours after surgery

  5. Postoperative systolic blood pressure

    Postoperative systolic blood pressure (mmHg)

    Measured: 48 hours after surgery

  6. Postoperative diastolic blood pressure

    Postoperative diastolic blood pressure (mmHg)

    Measured: 48 hours after surgery

  7. Postoperative oxygen saturation

    Postoperative oxygen saturation (%)

    Measured: 48 hours after surgery

  8. Length of hospital stay

    Postoperative hospital stay length (hours)

    Measured: 168 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

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
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563587
Sponsor's protocol ID
HGNAE-02
Other IDs
pecm830703
Status last verified
Sep 2015
First submitted
11 Sep 2015
Last updated
30 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Guzmán SV, Torres HJ, Plascencia HA, Castellanos MJ, Quintanilla MR. Cultura hospitalaria y el proceso narrativo en el niño enfermo. Estudio sobre las Culturas Contemporáneas. 2011 jul; XVII (33): 23-44

  • González ML, Gallardo DE. Calidad de la atención médica: La diferencia entre la vida o la muerte. Revista digital universitaria UNAM. 2012 Ago; 13 (8)

  • Hernandez PE, Rabadan RJ. Hospitalization, a break in the child´s life. Educational attention in infantile hospitalized population. Perspectiva Educacional. 2013 Ene; 52 (1):167-181

  • Meisel V, Chellew K, Ponsell E, Ferreira A, Bordas L, Garcia-Banda G. [The effect of "hospital clowns" on distress and maladaptive behaviours of children who are undergoing minor surgery]. Psicothema. 2009 Nov;21(4):604-9. Spanish.

    PubMed 19861106

  • Griffin GD, Charron D, Al-Daccak R. Post-traumatic stress disorder: revisiting adrenergics, glucocorticoids, immune system effects and homeostasis. Clin Transl Immunology. 2014 Nov 14;3(11):e27. doi: 10.1038/cti.2014.26. eCollection 2014 Nov.

    PubMed 25505957

  • Guyton y Hall. Tratado de Fisiología médica. Editorial ELSEVIER. 2011; 12: 1052-1055

  • Heden LE, von Essen L, Ljungman G. Effect of morphine in needle procedures in children with cancer. Eur J Pain. 2011 Nov;15(10):1056-60. doi: 10.1016/j.ejpain.2011.05.010. Epub 2011 Jun 15.

    PubMed 21680210

  • Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.

    PubMed 24407716

  • Montero-Homs J. [Nocioceptive pain, neuropathic pain and pain memory]. Neurologia. 2009 Jul-Aug;24(6):419-22. Spanish.

    PubMed 19798608

  • Finley GA, Kristjansdottir O, Forgeron PA. Cultural influences on the assessment of children's pain. Pain Res Manag. 2009 Jan-Feb;14(1):33-7. doi: 10.1155/2009/763031.

    PubMed 19262914

  • Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. The role of state anxiety in children's memories for pain. J Pediatr Psychol. 2012 Jun;37(5):567-79. doi: 10.1093/jpepsy/jss006. Epub 2012 Feb 23.

    PubMed 22362922

  • Christian R, Ramos J, Susanibar C, Balarezo G. Laugh Therapy: A new field for healthcare professionals. Rev. Soc. Per. Med. Inter. 2004; 17(2)

  • Gendry S. Certified Laughter Yoga Teacher Workbook. American School of Laughter Yoga. 2013

  • Nasr SJ. No laughing matter: laughter is good psychiatric medicine. A case report. Current Psychiatry. 2013; 12(8): 20-25

  • Amez AJ, Díaz PM. Manejo del dolor en odontopediatría. Rev Estomatol Herediana. 2010; 20(3):166-171

Questions about this trial

What is this clinical trial studying?

A study testing Laughter therapy, Accompaniment without causing the laughter of children. and Conventional treatment in people with Pain, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.

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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Sep 2015. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Magda Ruth Pérez Cervantes, Pediatrician ((52)5550371200 ext. 5423, dagmacancer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain level (time frame: 48 hours after surgery). 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 NCT02563587, which also lists 30 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 30 Sep 2015.

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