Brief Title
Effectiveness of Psychological Interventions in Haemophilia
Official Title
Effectiveness of Two Psychological Interventions for Prevention and Management of Pain, Emotional Regulation and Promotion of Quality of Life in People With Haemophilia: a Randomized Controlled Trial
Brief Summary
The purpose of this study is to evaluate the relative effectiveness of two psychological interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and managing pain, regulating emotional state and improving quality of life in Portuguese PWH.
Detailed Description
22 (People with Haemophilia) PWH will be included in each group (Hypnosis, CBT and control-no intervention) (total=66). Sample size was calculated using G*Power 3.1.4 and considering the following assumptions: to perform a one-way ANOVA with fixed effects, a large effect size (f =0.4), a significance level (α - type I error) of 0.05 and a statistical power (1-β - type II error) of 0.80. The patients will be approached by clinicians of the Immunohaemotherapy Department and the psychologists for the explanation of the study, confidentiality and voluntary nature of participation. Patients who agree to participate will be asked to read and sign the Informed Consent document. Afterwards, the first assessment moment will take place in order to get a baseline assessment of each patient (T0: pre-test). Subsequently, the blind randomization to one of the 3 conditions will occur and the 4 individual intervention sessions will be scheduled, occurring in a weekly basis (90 minutes per session). The post-test assessment (T1) takes place one week after the last intervention session (in the 5th week), and the follow-up assessments (T2, T3 and T4) will occur subsequently at 3 months, 6 months and one year post-intervention. A physiological assessment will be performed at T1, T2 and T4. This will be performed through the collection of blood samples in order to achieve a systemic evaluation of pro-inflammatory and anti-inflammatory cytokines. A CBC (Complete Blood Count) with White Blood Count and C Reactive Protein (CRP) analysis will also be performed. Upon arrival at the Immunohaemotherapy Department (between 9:30 am and 1:30 pm), patients will undergo sample blood collection and EDTA-samples will be transported immediately to the lab. In the lab, blood samples are centrifuged 15 minutes at 3.000 rpm, and plasma aliquoted and stored in a freezer at -80 ºC, until further analysis. Plasma levels of cytokines (IL-6, IL-1β, TNF-α, IL-10) are assayed in duplicate using ultra-sensitive multiplex human ELISA kits (Life Technologies®). Functional Assessment of the joints will be performed through the Gilbert (based on clinical evaluation) and Pettersson Scores (based on X-ray and ultrasonography). All study procedures will comply with the applicable ethical guidelines.
Study Type
Interventional
Primary Outcome
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
Secondary Outcome
Health Related Quality of Life (HRQOL) at 1 week as assessed by A36Hemofilia-Qol
Condition
Haemophilia
Intervention
Hypnosis
Study Arms / Comparison Groups
Hypnosis
Description: Hypnosis for the prevention and management of pain, emotional regulation and promotion of quality of life in people with Haemophilia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
20
Start Date
January 9, 2018
Completion Date
December 31, 2018
Primary Completion Date
December 31, 2018
Eligibility Criteria
Inclusion Criteria: - Mild pr severe Haemophilia A or B - Age of 18 or older - Ability to write and read Exclusion Criteria: - Other comorbid life threatening diseases, such as cancer - Neurological or psychiatric deficits - Acquired Haemophilia
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Patrícia R Pinto, PhD, ,
Location Countries
Portugal
Location Countries
Portugal
Administrative Informations
NCT ID
NCT02870452
Organization ID
RCT520101.ID1825
Responsible Party
Principal Investigator
Study Sponsor
University of Minho
Collaborators
Hospital Sao Joao
Study Sponsor
Patrícia R Pinto, PhD, Principal Investigator, Life and Health Sciences Research Institute
Verification Date
March 2019