Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02158338
Other study ID # 389127
Secondary ID
Status Completed
Phase N/A
First received June 4, 2014
Last updated May 29, 2015
Start date June 2014
Est. completion date March 2015

Study information

Verified date May 2015
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Six studies have preceded this project. Three studies suggested that there is a significant connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg, 1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames, Skolek, & Brown, 2000; Madrid, Ames, Horner, Brown, & Navarrette, 2004; Madrid, Pennington, Brown & Wolfe, 2011).

This study proposes to study in a more thorough fashion the question of the incidence of bonding disruptions with between mothers and their children with asthma. This time there will be a larger sample, and more stringent criteria will used in assigning children to the asthma cohort. Through questions answered by mothers whose children have been said to have asthma, we will be able to decide if the children's respiratory conditions are likely to be attributable to asthma or more likely reflective of another respiratory condition such as vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Biological mothers of male and female children between 2 and 12 years of age who live with or have contact with their children

- English is the primary language of the biological mother

Exclusion Criteria:

- Mothers of children only below 2 or above 12 years of age

- Mothers of children thought to have a chronic health condition other than asthma

- Mothers who have already completed a questionnaire with another child

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Asthma
mothers who have children that have been diagnosed with respiratory issues
Non-asthma
mothers who have children that do not have a diagnosis of respiratory problems

Locations

Country Name City State
United States SUNY Upstate Medical University Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
Ran Anbar

Country where clinical trial is conducted

United States, 

References & Publications (16)

Anbar RD, Geisler SC. Identification of children who may benefit from self-hypnosis at a pediatric pulmonary center. BMC Pediatr. 2005 Apr 25;5(1):6. — View Citation

Anbar, R.D. Functional symptoms in pulmonology: taking your breath away. In: Ran D. Anbar (ed), Functional Symptoms in Pediatric Disease: A Clinical Guide. New York, NY: Springer, 2014; 47-58.

Annesi-Maesano I, Moreau D, Strachan D. In utero and perinatal complications preceding asthma. Allergy. 2001 Jun;56(6):491-7. — View Citation

Feinberg, Steven. Degree of maternal infant bonding and its relationship to pediatric asthma and family environments. Unpublished doctoral dissertation, Professional School of Psychology, San Francisco, 1988.

Kero J, Gissler M, Grönlund MM, Kero P, Koskinen P, Hemminki E, Isolauri E. Mode of delivery and asthma -- is there a connection? Pediatr Res. 2002 Jul;52(1):6-11. — View Citation

Klaus, M. H., & Kennen, J. H. Maternal-infant bonding. St. Louis, MO: C. V. Mosby, 1976.

Klinnert MD, Nelson HS, Price MR, Adinoff AD, Leung DY, Mrazek DA. Onset and persistence of childhood asthma: predictors from infancy. Pediatrics. 2001 Oct;108(4):E69. — View Citation

Kozyrskyj AL, Mai XM, McGrath P, Hayglass KT, Becker AB, Macneil B. Continued exposure to maternal distress in early life is associated with an increased risk of childhood asthma. Am J Respir Crit Care Med. 2008 Jan 15;177(2):142-7. Epub 2007 Oct 11. — View Citation

Madrid A. Helping children with asthma by repairing maternal-infant bonding problems. Am J Clin Hypn. 2005 Oct-2006 Jan;48(2-3):199-211. — View Citation

Mäntymaa M, Puura K, Luoma I, Salmelin R, Davis H, Tsiantis J, Ispanovic-Radojkovic V, Paradisiotou A, Tamminen T. Infant-mother interaction as a predictor of child's chronic health problems. Child Care Health Dev. 2003 May;29(3):181-91. — View Citation

Nafstad P, Samuelsen SO, Irgens LM, Bjerkedal T. Pregnancy complications and the risk of asthma among Norwegians born between 1967 and 1993. Eur J Epidemiol. 2003;18(8):755-61. — View Citation

Pennington, D. Events associated with maternal-infant bonding deficits and severity of pediatric asthma. Unpublished doctoral dissertation, Professional School of Psychology, San Francisco, 1991.

Roduit C, Scholtens S, de Jongste JC, Wijga AH, Gerritsen J, Postma DS, Brunekreef B, Hoekstra MO, Aalberse R, Smit HA. Asthma at 8 years of age in children born by caesarean section. Thorax. 2009 Feb;64(2):107-13. doi: 10.1136/thx.2008.100875. Epub 2008 Dec 3. — View Citation

Schwartz, M.P. Incidence of events associated with maternal-infant bonding disturbance in a pediatric population. Unpublished doctoral dissertation, Rosebridge Graduate School, Walnut Creek, 1988.

Wright RJ, Cohen S, Carey V, Weiss ST, Gold DR. Parental stress as a predictor of wheezing in infancy: a prospective birth-cohort study. Am J Respir Crit Care Med. 2002 Feb 1;165(3):358-65. — View Citation

Wright RJ, Visness CM, Calatroni A, Grayson MH, Gold DR, Sandel MT, Lee-Parritz A, Wood RA, Kattan M, Bloomberg GR, Burger M, Togias A, Witter FR, Sperling RS, Sadovsky Y, Gern JE. Prenatal maternal stress and cord blood innate and adaptive cytokine responses in an inner-city cohort. Am J Respir Crit Care Med. 2010 Jul 1;182(1):25-33. doi: 10.1164/rccm.200904-0637OC. Epub 2010 Mar 1. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects with asthma and/or maternal infant bonding issues A questionnaire will be scored by a pediatric pulmonologist and a psychologist Day 1 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A