The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial
Phase: NA
Conditions: Transplant;Failure,Kidney
Sponsor: University of Malaya

The effectiveness of single session 20-minute mindful breathing in symptom control in 
kidney transplant recipients: a randomised controlled trial 
 
Version 1.0 
Date 4/11/2020 
 
Introduction 
Therapeutic mindfulness is the practice of being aware of the present moment1. Previous 
studies have suggested benefit of mindfulness-based therapy for improving general health 
conditions. The body of evidence to date included both clinical trials, as well as observational 
and qualitative studies showing evidence of benefit2, 3, 4. While the majority of outcomes 
measured involved improvement in psychological well-being, a few other measured outcomes 
includes looking at physiological changes in response to mindfulness-based therapy5. The scope 
of study participants were wide, with involvement of healthy volunteers to palliative care 
patients, as well as patient caregivers. However, a new perspective of study is worth discovering 
based on population of kidney transplant recipients suffer from varying degree of symptoms. 
From our literature review, two RCTs were identified which have reported positive association in 
psychosocial symptoms reduction through mindfulness-based interventions among solid organ 
transplant recipients6, 7. Both studies involved multiple sessions of mindfulness-based 
intervention and long-term outcome measurement.   
 
In this study, we aim to study the effectiveness of single session 20-minute mindful breathing in 
symptom control in kidney transplant recipients. Results from this study will help clinicians to 
manage patients for better symptom control, by offering multi-modality approaches in future 
patient care, more so in patients who prefer non-pharmacological interventions or are 
experiencing side effects of the pharmacological management. 
 
Objectives 
To study the effectiveness of single session 20-minute mindful breathing in symptom control in 
kidney transplant recipients. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Methodology 
A randomized controlled trial was conducted in renal transplant clinic of a tertiary center. A 
total of 192 adult kidney transplant recipients (KTR) attending renal transplant clinic were 
screened for eligibility. Subjects who aged ≥ 18-year-old, scored ≥ 4 in at least 1 symptom at 0-
minute based on Edmonton Symptom Assessment System (ESAS), and consented to participate 
were being recruited. Subjects with underlying psychiatric comorbidities and who were not able 
to communicate were excluded. A total of 60 subjects were randomized equally into control and 
intervention arms by electronic number randomizer. Subjects in control arm received only 
standard care. Subjects in intervention arm received a single session 20-minute guided mindful 
breathing session in addition to standard care. Subjects in both arms were requested to rate 
their symptoms using ESAS at 20-minute. Data collected were analyzed using SPSS version 21. 
 
 
Ethics 
Medical ethic approval was obtained from the medical ethic committee of University Malaya 
Medical Center. Informed consent was obtained from all the subjects of the study. The study 
was conducted according to the Good Clinical Practice (GCP) guideline. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Intervention 
Intervention involves a single session 20-minute mindful breathing guided by the investigator 
using a uniform script (as below). Subjects in the control group will be told to continue with their 
activities for 20 minutes.   
 
Step 1 (5 minutes): Identifying the in- breath and outbreath 
Make yourself comfortable. Relax your body. Close your eyes gently. Take two deep breaths 
slowly. Then, breathe naturally. Notice the flow of air through your nose. Rest your attention 
gently on the breath. Breathing in, you know you are breathing in. Breathing out, you know 
you are breathing out. In – out, in – out, in – out. If you are distracted by any sounds, body 
sensations, thoughts or feelings, gently come back to your breath. Be aware of your in-
breath and outbreath for the next few minutes. 
 
Step 2 (5 minutes): Following the entire length of the breath 
Continue to relax your body with your eyes closed. Continue to pay attention to your breath. 
Follow the entire length of your breath. Follow the beginning, the middle and the end of 
your in- breath, and the beginning, middle and the end of your out-breath. If you are 
breathing in a long breath, you know you are breathing in a long breath. If you are breathing 
in a short breath, you know you are breathing in a short breath. If you are breathing out a 
long breath, you know you are breathing out a long breath. If you are breathing out a short 
breath, you know you are breathing out a short breath. Do not force yourself to take a long 
or short breath. Just breathe naturally. Be aware of the entire length of the breath. In – in – 
in, out – out – out, in – in – in, out – out – out. If you are distracted by any sounds, body 
sensations, thoughts or feelings, gently come back to your breath. Follow the entire length 
of your breath for the next few minutes. 
 
Step 3 (5 minutes): Bringing the mind back to the body 
As you follow the entire length of your breath, bring your mind back to your body. Instead of 
thinking about the past or future, bring your mind back to now. Bring your mind and body 
together as one. As you breathe in, feel your whole body moving with your breathing in. As 
you breathe out, feel your whole body moving with your breathing out. Breathing in, you are 
aware of your whole body as you are breathing in. Breathing out, you are aware of your 
whole body as you are breathing out. Feel the different parts of your body as you breathe in 
and out. Then, feel the body as a whole, fully united with your mind. Feel the wholeness of 
yourself with each breath for the next few minutes. 
 
Step 4 (5 minutes): Relaxing the body 
Once your breathing is harmonious, your body will relax naturally. Feel whether there is any 
tension in your body. Breathe and relax the tension one by one, from the top to the bottom. 
Relax your head, face, neck, arms, forearms, hands, chest, abdomen, legs, feet. Then relax 
your whole body all at once. Breathing in, you calm your body when you are breathing in. 
Breathing out, you smile. Again, breathing in, you calm your body when you are breathing in. 
Breathing out, you smile. In – out – calm – smile, in – out – calm – smile, in – out – calm – 
smile. Feel your breath flowing through your body and calming your body. Feel your breath 
leaving your body and smile. Continue to relax your whole body for the next few minutes 

Outcome measured 
 
 
 
 
 
 
 
 
 

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