Original Article|Articles in Press

Development and Validation of an Evidence-Based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors

Published:November 15, 2022DOI:


      • Healthcare intervention requires evidence-based practice.
      • The development process of an evidence-based breathing exercise intervention protocol for chronic pain management following the MRC framework has been thoroughly reported.
      • The study provided an example for other researchers in the development of healthcare intervention.
      • This developed breathing exercise intervention protocol will be further evaluated in future clinical studies.



      Breathing exercise has been utilized as a promising approach to pain management in cancer survivors. However, the development process of the breathing exercise intervention protocol was rarely reported.


      To develop an evidence-based breathing exercise intervention protocol for chronic pain management in breast cancer survivors and to provide a detailed account of the intervention development process.


      The study design was guided by the Medical Research Council Framework for Developing and Evaluating Complex Intervention. The breathing exercise intervention development process adopted phase one of the Medical Research Council Framework for Developing and Evaluating Complex Intervention framework. The content validity index was applied to determine the consensus of the appropriateness of the breathing exercise intervention protocol among the panel experts.


      The preliminary breathing exercise intervention protocol was developed based on fight-or-flight theory and vagus nerve theory, and the best available research evidence identified from seven systematic reviews, three clinical trials, and four practice recommendations. The breathing exercise intervention was designed as slow deep pursed-lip breathing with a time ratio of inspiration to expiration 1:2-3. The intensity of the breathing exercise was determined as 3 to 5 sessions a day, 5 minutes per session, for 4 weeks. The content validity of the breathing exercise intervention protocol was excellent as consensus was achieved among all panel experts with both the item-level and scale-level CVIs reaching 1.0.


      This study developed an evidence-based breathing exercise intervention protocol for chronic pain management in breast cancer survivors. The protocol is well-supported by the relevant theories, research evidence, practice recommendations, and experts’ consensus.
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        • Altice C.K.
        • Banegas M.P.
        • Tucker-Seeley R.D.
        • Yabroff K.R.
        Financial hardships experienced by cancer survivors: A systematic review.
        Journal of the National Cancer Institute. 2017; 109: djw205
        • Anderson B.E.
        • Bliven K.C.H.
        The use of breathing exercises in the treatment of chronic, nonspecific low back pain.
        Journal of Sport Rehabilitation. 2017; 26: 452-458
        • Anderson T.A.
        The opioid wars—CON: The risks of opioids for pain management outweigh the benefits.
        Clinical Journal of Pain. 2019; 35: 463-467
        • Anekar A.A.
        • Cascella M.
        WHO analgesic ladder.
        StatPearls. Retrieved Month 15 March 2022. 2021;
        • Bagheriyan S.
        • Borhani F.
        • Abbaszadeh A.
        • Ranjbar H.
        The effects of regular breathing exercise and making bubbles on the pain of catheter insertion in school age children.
        Iranian Journal of Nursing and Midwifery Research. 2011; 16: 174-180
        • Bjerkeset E.
        • Röhrl K.
        • Schou-Bredal I.
        Symptom cluster of pain, fatigue, and psychological distress in breast cancer survivors: Prevalence and characteristics.
        Breast Cancer Research and Treatment. 2020; 180: 63-71
        • Bozorg-Nejad M.
        • Azizkhani H.
        • Ardebili F.M.
        • Mousavi S.K.
        • Manafi F.
        • Hosseini A.F.
        The effect of rhythmic breathing on pain of dressing change in patients with burns referred to Ayatollah Mousavi hospital.
        World Journal of Plastic Surgery. 2018; 7: 51-57
        • Brown R.P.
        • Gerbarg P.L.
        • Muench F.
        Breathing practices for treatment of psychiatric and stress-related medical conditions.
        Psychiatric Clinics. 2013; 36: 121-140
        • Can G.
        • Mushani T.
        • Rajhi B.H.A.L.
        • Brant J.M.
        The global burden of cancer pain.
        Seminars in Oncology Nursing. 2019; 35: 315-321
        • Carlson C.L.
        Effectiveness of the World Health Organization cancer pain relief guidelines: An integrative review.
        Journal of Pain Research. 2016; 9: 515-534
        • Chakravarthy K.
        • Chaudhry H.
        • Williams K.
        • Christo P.J.
        Review of the uses of vagal nerve stimulation in chronic pain management.
        Current Pain and Headache Reports. 2015; 19: 54
        • De Couck M.
        • Nijs J.
        • Gidron Y.
        You may need a nerve to treat pain: the neurobiological rationale for vagal nerve activation in pain management.
        Clinical Journal of Pain. 2014; 30: 1099-1105
        • Deng G.
        Integrative medicine therapies for pain management in cancer patients.
        Cancer Journal (Sudbury, Mass.). 2019; 25: 343-348
        • Eaton L.H.
        • Brant J.M.
        • McLeod K.
        • Yeh C.
        Nonpharmacologic pain interventions: a review of evidence-based practices for reducing chronic cancer pain.
        Clinical Journal of Oncology Nursing. 2017; 21 (Suppl): 54-70
        • Faling L.J.
        Pulmonary rehabilitation—physical modalities.
        Clinics in Chest Medicine. 1986; 7: 599-618
        • Greenberg E.N.
        The consequences of chronic pain.
        Journal of Pain & Palliative Care Pharmacotherapy. 2012; 26: 64-67
        • Guan N.
        • Beng T.
        • Sue-Yin L.
        • Kanagasundram S.
        The effect of 5-min mindful breathing on pain in palliative care cancer patients: a randomized controlled study.
        Indian Journal of Palliative Care. 2021; 27: 83-88
        • Gupta K.
        • Prasad A.
        • Nagappa M.
        • Wong J.
        • Abrahamyan L.
        • Chung F.F.
        Risk factors for opioid-induced respiratory depression and failure to rescue: A review.
        Current Opinion in Anaesthesiology. 2018; 31: 110-119
        • Hamood R.
        • Hamood H.
        • Merhasin I.
        • Keinan-Boker L.
        Chronic pain and other symptoms among breast cancer survivors: Prevalence, predictors, and effects on quality of life.
        Breast Cancer Research and Treatment. 2018; 167: 157-169
        • Harrington C.B.
        • Hansen J.A.
        • Moskowitz M.
        • Todd B.L.
        • Feuerstein M.
        It's not over when it's over: long-term symptoms in cancer survivors—a systematic review.
        International Journal of Psychiatry in Medicine. 2010; 40: 163-181
        • Hikmat R.
        • Rahayu U.
        • Pebrianti S.
        • Cahyani E.M.
        • Sari C.P.
        • Afrilia G.
        Post-operative pain management with non-pharmacological interventions in patients undergoing breast cancer surgery: A systematic scoping review.
        Journal of Palembang Nursing Studies. 2022; 1: 125-133
        • Huang T.
        • Hao B.
        History and modern application of chinese physical and breathing exercises.
        Psychosomatic Medicine. 2019; 1: 3
        • Jafari H.
        • Courtois I.
        • Van den Bergh O.
        • Vlaeyen J.W.
        • Van Diest I.
        Pain and respiration: A systematic review.
        Pain. 2017; 158: 995-1006
        • Jara C.
        • Del Barco S.
        • Grávalos C.
        • Hoyos S.
        • Hernández B.
        • Muñoz M.
        • Quintanar T.
        • Meana J.A.
        • Rodriguez C.
        • de Las Peñas R
        SEOM clinical guideline for treatment of cancer pain (2017).
        Clinical and Translational Oncology. 2018; 20: 97-107
        • Jayawardena R.
        • Ranasinghe P.
        • Ranawaka H.
        • Gamage N.
        • Dissanayake D.
        • Misra A.
        Exploring the therapeutic benefits of pranayama (yogic breathing): a systematic review.
        International Journal of Yoga. 2020; 13: 99-110
        • Jerath R.
        • Edry J.W.
        • Barnes V.A.
        • Jerath V.
        Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system.
        Medical Hypotheses. 2006; 67: 566-571
        • Johnson R.L.
        • Wilson C.G.
        A review of vagus nerve stimulation as a therapeutic intervention.
        Journal of Inflammation Research. 2018; 11: 203-213
        • Kaur N.
        • Kumar A.
        • Saxena A.K.
        • Gupta A.
        • Grover R.K.
        Postmastectomy chronic pain in breast cancer survivors: An exploratory study on prevalence, characteristics, risk factors, and impact on quality of life.
        Indian Journal of Surgery. 2018; 80: 592-598
        • Keenan A.
        • Keithley J.K.
        Integrative review: effects of music on cancer pain in adults.
        Oncology Nursing Forum. 2015; 42: E368-E375
        • Kezele T.G.
        • Babić M.
        • Kauzlarić-Živković T.
        • Gulić T.
        Combined upper limb and breathing exercise programme for pain management in ambulatory and non-ambulatory multiple sclerosis individuals: Part II analyses from feasibility study.
        Neurological Sciences. 2020; 41: 65-74
        • Kumaran E.M.
        Alteration in nasal cycle rhythm as an index of the diseased condition.
        in: Gaze D.C. Pathophysiology: altered physiological states. Intechopen, 2018: 23-34
        • Leysen L.
        • Beckwee D.
        • Nijs J.
        • Pas R.
        • Bilterys T.
        • Vermeir S.
        • Adriaenssens N.
        Risk factors of pain in breast cancer survivors: A systematic review and meta-analysis.
        Supportive Care in Cancer. 2017; 25: 3607-3643
        • Li Y.
        • Xing X.
        • Shi X.
        • Yan P.
        • Chen Y.
        • Li M.
        • Zhang W.
        • Li X.
        • Yang K.
        The effectiveness of music therapy for patients with cancer: A systematic review and meta-analysis.
        Journal of Advanced Nursing. 2020; 76: 1111-1123
        • Lynn M.R.
        Determination and quantification of content validity.
        Nursing Research. 1986; 35: 382-385
        • McCorry L.K.
        Physiology of the autonomic nervous system.
        American Journal of Pharmaceutical Education. 2007; 71: 78
        • Minton O.
        • Stone P.
        How common is fatigue in disease-free breast cancer survivors? a systematic review of the literature.
        Breast Cancer Research and Treatment. 2008; 112: 5-13
        • Mohamed S.A.
        The effects of positioning and pursed-lip breathing exercise on dyspnea and anxiety status in patients with chronic obstructive pulmonary disease.
        Journal of Nursing Education and Practice. 2019; 9: 41-51
        • Naik G.S.
        • Gaur G.
        • Pal G.
        Effect of modified slow breathing exercise on perceived stress and basal cardiovascular parameters.
        International Journal of Yoga. 2018; 11: 53-58
        • Nattah F.M.
        • Abbas W.A.K.
        Assessment of level of pain and its relation with breathing exercise in the first stage of labour among Primi mothers at Hilla teaching hospital.
        European Journal of Scientific Research. 2016; 135: 121-128
        • Parsa P.
        • Khodakaramy B.
        • Farhadian M.
        • Fazli F.
        The effect of breathing techniques on maternal behavioral changes against labor pain and APGAR score in primiparous women.
        Pajouhan Scientific Journal. 2020; 18: 107-113
        • Perciavalle V.
        • Blandini M.
        • Fecarotta P.
        • Buscemi A.
        • Di Corrado D.
        • Bertolo L.
        • Fichera F.
        • Coco M.
        The role of deep breathing on stress.
        Neurological Sciences. 2017; 38: 451-458
        • Prem V.
        • Sahoo R.C.
        • Adhikari P.
        Effect of diaphragmatic breathing exercise on quality of life in subjects with asthma: A systematic review.
        Physiotherapy Theory and Practice. 2013; 29: 271-277
        • Satija A.
        • Ahmed S.M.
        • Gupta R.
        • Ahmed A.
        • Rana S.P.S.
        • Singh S.P.
        • Mishra S.
        • Bhatnagar S.
        Breast cancer pain management-a review of current & novel therapies.
        Indian Journal of Medical Research. 2014; 139: 216-225
        • Skivington K.
        • Matthews L.
        • Simpson S.A.
        • Craig P.
        • Baird J.
        • Blazeby J.M.
        • Boyd K.A.
        • Craig N.
        • French D.P.
        • McIntosh E.
        • Petticrew M.
        • Rycroft-Malone J.
        • White M.
        • Moor L.
        A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.
        BMJ. 2021; 374: n2061
        • Strollo S.E.
        • Fallon E.A.
        • Gapstur S.M.
        • Smith T.G.
        Cancer-related problems, sleep quality, and sleep disturbance among long-term cancer survivors at 9-years post diagnosis.
        Sleep Medicine. 2020; 65: 177-185
        • Thronæs M.
        • Balstad T.R.
        • Brunelli C.
        • Løhre E.T.
        • Klepstad P.
        • Vagnildhaug O.M.
        • Kaasa S.
        • Knudsen A.K.
        • Solheim T.S.
        Pain management index (PMI)—does it reflect cancer patients’ wish for focus on pain?.
        Supportive Care in Cancer. 2020; 28: 1675-1684
        • Tomas-Carus P.
        • Branco J.C.
        • Raimundo A.
        • Parraca J.A.
        • Batalha N.
        • Biehl-Printes C.
        Breathing exercises must be a real and effective intervention to consider in women with fibromyalgia: A pilot randomized controlled trial.
        Journal of Alternative and Complementary Medicine. 2018; 24: 825-832
        • Van Den Beuken-Van M.H.
        • Hochstenbach L.M.
        • Joosten E.A.
        • Tjan-Heijnen V.C.
        • Janssen D.J.
        Update on prevalence of pain in patients with cancer: systematic review and meta-analysis.
        Journal of Pain and Symptom Management. 2016; 51: 1070-1090
        • Van der Schans C.
        • De Jong W.
        • Kort E.
        • Wijkstra P.
        • Koeter G.
        • Postma D.
        • van der Mark T.W
        Mouth pressures during pursed lip breathing.
        Physiotherapy Theory and Practice. 1995; 11: 29-34
        • Wang H.
        • Tan J.-Y.
        • Liu X.
        • Wang T.
        Breathing exercise for pain management in cancer survivors: A systematic review.
        Preprints, 20222022030156
        • Wang K.
        • Yee C.
        • Tam S.
        • Drost L.
        • Chan S.
        • Zaki P.
        • Rico V.
        • Ariello K.
        • Dasios M.
        • Lam H.
        • DeAngelis C.
        • Chow E.
        Prevalence of pain in patients with breast cancer post-treatment: A systematic review.
        Breast. 2018; 42: 113-127
        • Wang Y.Q.
        • Liu X.
        • Jia Y.
        • Xie J.
        Impact of breathing exercises in subjects with lung cancer undergoing surgical resection: A systematic review and meta-analysis.
        Journal of Clinical Nursing. 2019; 28: 717-732
        • Wu Y.-C.
        A disorder of qi: Breathing exercise as a cure for neurasthenia in Japan, 1900–1945.
        Journal of the History of Medicine and Allied Sciences. 2016; 71: 322-344
        • Wurjatmiko A.T.
        The effects of music therapy intervention on the pain and anxiety levels of cancer patient: A systematic review.
        International Journal of Nursing Education. 2019; 11: 414
        • Yuksel H.
        • Cayir Y.
        • Kosan Z.
        • Tastan K.
        Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: a randomized controlled trial.
        Journal of Integrative Medicine. 2017; 15: 456-461
        • Yusoff M.S.B.
        ABC of content validation and content validity index calculation.
        Resource. 2019; 11: 49-54
        • Zaccaro A.
        • Piarulli A.
        • Laurino M.
        • Garbella E.
        • Menicucci D.
        • Neri B.
        • Gemignani A.
        How breath-control can change your life: A systematic review on psycho-physiological correlates of slow breathing.
        Frontiers in Human Neuroscience. 2018; 12: 353
      1. American Lung Association. (2021). Pursed lip breathing. Retrieved July 27, 2022, from