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STUDY PROTOCOL: Randomized controlled trial on the impact of a STRESS REDUCTION PROGRAM on psychological well-being in endometriosis Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG

STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

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Page 1: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

STUDY PROTOCOL: Randomized controlled trial on the impact of

a STRESS REDUCTION PROGRAM on psychological well-being in endometriosis

Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG

BRAZIL 1

HC-UFMG

Page 2: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

Introduction!  Endometriosis and Chronic Pelvic Pain (CPP)

Benign disease, estrogen dependent, endometrial implants outside the uterus. Asymptomatic, infertility, chronic pelvic pain (Giudice & Kao, 2004 Lancet; Kennedy et al., 2005 Hum Reprod)

!  Psychosocial aspects of endometriosis Heavy load on the body physically and emotionally; long time until diagnosis (Ballard, 2006 Fertil Steril)

!  Endometriosis x Chronic Stress Anxiety and chronic stress can be associated with endometriosis and CPP (Abrão, 2000 Revinter; Almeida, 2001 Femina) Endometriosis and CPP represent psychological and physical stressors!high incidence of depression (Lorençatto, 2002 Rev Assoc Med Bras) Symptoms of chronic stress: similar to cancer, HTN, cardiac rehab (Domar, 1993 PsychObG) Psychological changes = depression, anxiety, interpersonal problems, suppressed anger, frustration, feelings of inferiority and guilt (Cox, 2006 Fertil Steril)

!  Mindfulness-Based Stress Reduction Program (MBSR) Mind-Body Techniques to help dealing with stressors (Gordon, 2004 J Trauma Stress) Anti-Stress Program – ASP (Brazilian adaptation Mindfulness-Based Stress Reduction Program)

2 (Sara Paiva, M.D., Ph.D – BRAZIL)

Page 3: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

Stress and Body Response

3

Body imbalance

Physiological changes

Phase 1 ALERT

Phase 2 RESISTANCE

Phase 3 EXHAUSTION

!  Fight or flight mechanism: Sympathetic Nervous System Adrenaline

!  Muscle relaxation mechanism: Parasympathetic Nervous System Acetilcholine

Opposition to the Fight of Flight

Muscle Relaxation

Reduction of Stress Symptoms

(Sara Paiva, M.D., Ph.D – BRAZIL)

Page 4: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

Anti-Stress Program (ASP)!  2004 - 2007 GUSOM: Ph.D. + MBSR Training

!  2008 UFMG: INFERTILITY

!  2013 UNIBH: Medical Students and Professors

4 (Sara Paiva, M.D., Ph.D – BRAZIL)

Professors Medical Students

Before After

S

PS-1

0

STRESS Perception Scale (SPS-10)

18.8

10

21.6

* 14.6

(p = 0,06) (p = 0,04)

Before After

B

EC

K In

vent

ory

BECK Inventory for Depression

ns 2,4

7.4

9.3

ns 3,5

Professors Medical Students (p = 0,35) (p = 0,08)

Page 5: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

Anti-Stress Program (ASP)

5 (Sara Paiva, M.D., Ph.D – BRAZIL)

2015 UFMG: ENDOMETRIOSIS ! To teach skills that promote self-knowledge, self-connection and

self-care "! Stress coping strategies to deal with endometriosis and CPP!  Inclusion and exclusion criteria // Participants // Group meetings

Patients with endometriosis

Control group Clinical Treatment

Questionnaires Day one and

after 12 weeks

Study group Clinical Treatment + ASP

Questionnaires Day one and

after 12 weeks

Page 6: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

6 (Sara Paiva, M.D., Ph.D – BRAZIL)

Gro

up S

essi

on

Check in

MBSR Techniques

Drawing

Autogenic training

Biofeedback

Mindfulness meditation

Guided imagery

Group processing

Instruments of evaluation

Questionnaires PGWBI / BECK

inventory / SPE-10

Drawings

Thermostat Oximeter

Saliva

Blood

Anti-Stress Program (ASP)

Page 7: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

X Muscle relaxation

mechanism

PNS Acetilcholine

Fight of flight mechanism

SNS Adrenaline

STRESS

(Sara Paiva, M.D., Ph.D – BRAZIL)

Conclusions

!  Endometriosis + CPP = chronic stress / physical and psychological symptoms

!  ASP = Women with endometriosis can engage in self-care (mindfulness, self-awareness and self-reflection)

!  Increased mindfulness = changes in mood and perceived stress (improved impact on disease-related stress coping)

7

Page 8: STUDY PROTOCOL: Randomized controlled trial on the impact ......Sara de Pinho Cunha Paiva, M.D., Ph.D. Hospital das Clínicas da UFMG BRAZIL 1 HC-UFMG . Introduction! Endometriosis

Impact of a STRESS REDUCTION PROGRAM on psychological well-being in endometriosis

Georgetown University (EUA)

What happens to the body... Can influence the mind!!!! Acknowledgements: Georgetown University (USA) Universidade Federal de Minas Gerais UFMG (BRAZIL) Centro Universitário de Belo Horizonte UNIBH (BRAZIL) Dr. Aroldo F. Camargos; Dra. Márcia M. Carneiro; Dr. Fernando M. Reis (BRAZIL)

(Sara Paiva, M.D., Ph.D – BRAZIL) 8

Did you SALIVATE???? ! GUIDED IMAGERY