Acupuncture and Reflexology for Insomnia: A Feasibility Study
Abstract
Objective: To assess the feasibility of patient recruitment and retention, logistics of intervention and outcome measure sensitivity for a study designed to investigate the use of acupuncture and reflexology for the management of insomnia. Design: Feasibility study for a randomised controlled trial. Setting: University of Ulster Clinic. Patients: Thirteen participants with sleep disturbances. Interventions: Participants were randomised to receive one of three treatments, either: acupuncture (n = 5), reflexology (n = 4) or music therapy (n = 4). These treatments were administered six times over a 3-week period. Main outcome measures: The Pittsburgh Sleep Quality Index (PSQI) and Short Form 36 version 2 (SF-36v2) were recorded at baseline, post-treatment and follow-up. Each participant also completed a Sleep Diary. Results: Ten participants completed treatment. In the acupuncture and reflexology groups, a clinically relevant improvement in two out of three participants was observed on the PSQI following treatment. Music therapy produced no clinically important improvements. This study has demonstrated the feasibility of conducting an RCT on the effect of acupuncture and reflexology in primary insomnia using PSQI as the primary outcome measure. Modifications for a more rigorous study design have been discussed. Results from such a study would address the lack of high-quality evidence for the effectiveness of such therapies.
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A change of 3.0 is considered a clinically important difference in the PSQI score.
“A change of 3.0 is considered a clinically important difference in the PSQI score [30].”
From Online prenatal trial in mindfulness sleep management (OPTIMISM): Protocol for a pilot randomized controlled trial (2020) · cites this paper as [30]
The effect of exercise on PSQI in favor of the intervention was considered small.
“Therefore, the effect of exercise on PSQI in favor of the intervention (low-quality evidence) was considered small.”
From Exercise can improve sleep quality: A systematic review and meta-analysis (2018) · cites this paper as Hughes et al., 2009
The positive effect of exercise on sleep quality was thought to be small, as PSQI scores dropped by 3.17 points, which is near the three-point minimum clinically significant difference.
“As to sleep quality, a three-point change in PSQI scores is considered indicative of a minimum clinically significant difference. ( 53 ) In this study, PSQI scores dropped by 3.17 points. Therefore, the positive effect of exercise on sleep quality (very low quality of evidence) was thought to be small.”
From Physical exercise as a therapeutic approach for adults with insomnia: Systematic review and meta-analysis (2022) · cites this paper as [53]
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“To assess the treatment effect on insomnia symptoms (primary outcome) and sleep quality and fatigue, the Insomnia Severity Index (ISI) [22], Pittsburgh Sleep Quality Index (PSQI) [26], Fatigue Severity Scale (FSS) [27], and Modified Fatigue Impact Scale (MFIS) [28] were collected pre- and postintervention using the RE…”
BackgroundInfluentialNolan, B. J., Frydman, A. S., Leemaqz, S., Carroll, M., Grossmann, M., Zajac, J. D., & Cheung, A. S. (2022) · Endocrine Connections · doi:10.1530/ec-22-0170 · Cited by 12 · see citing works
Oswald, L. B., Eisel, S. L., Tometich, D. B., Bryant, C., Hoogland, A. I., Small, B. J., Apte, S. M., Chon, H. S., Shahzad, M. M. K., Gonzalez, B. D., et al. (2022) · Health Psychology · doi:10.1037/hea0001190 · Cited by 11 · see citing works
Kim, J., Kim, G., Kim, S. W., Oh, J.-K., Park, M. S., Kim, Y., & Kim, T.-H. (2021) · The Spine Journal · doi:10.1016/j.spinee.2021.01.007 · Cited by 11 · see citing works
Rizzini, F. L., Gómez-González, A. M., Conejero-Cisneros, R., Romero-Blanco, M. J., Maldonado-Barrionuevo, A., Salinas-Sánchez, P., & Jiménez-Navarro, M. F. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph192416675 · Cited by 11 · see citing works
“In our study we decided to consider a change of 3 or more points to indicate the minimum clinically significant difference, in accordance with Hughes [29].”
BackgroundResultBenham, J. L., Booth, J. E., Goldfield, G. S., Friedenreich, C. M., Rabi, D. M., & Sigal, R. J. (2023) · Clinical Endocrinology · doi:10.1111/cen.14900 · Cited by 12 · see citing works
“A minimal clinically important difference in the PSQI is a change in score of 3 or greater.(27) To evaluate sleep disturbance in further detail, a validated three‐factor scoring model was also used.”
MethodSleep quality and lymphedema in breast cancer survivors: a mixed method analysis
Bock, K. J., Peltzer, J. N., Liu, W., Colgrove, Y., Smirnova, I. V., & Siengsukon, C. F. (2024) · Journal of Cancer Survivorship · doi:10.1007/s11764-023-01516-9 · Cited by 12 · see citing works
“The accepted minimal clinically important difference for PSQI is considered a change of three points or more [41, 42].”
Loureiro, A. P. C., Burkot, J., Oliveira, J., & Barbosa, J. M. (2021) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2021.101523 · Cited by 10 · see citing works
Tanner, N. J., Schultz, B. J., Calderón, C., Fithian, A. T., Segovia, N. A., Bishop, J. A., & Gardner, M. J. (2022) · Injury · doi:10.1016/j.injury.2022.10.011 · Cited by 10 · see citing works
Androgen Deprivation and Sleep Disturbance
Myers, J. S., Siengsukon, C. F., Sherman, J., Shen, X., Ptomey, L. T., Montgomery, R. N., Bock, K. J., Rice, A. M., Parker, W. P., & Maliski, S. L. (2022) · Cancer Nursing · doi:10.1097/ncc.0000000000001100 · Cited by 10 · see citing works
Ughreja, R. A., Venkatesan, P., Gopalakrishna, D. B., Singh, Y. P., & Vani Lakshmi, R. (2024) · Journal of Chinese Integrative Medicine · doi:10.1016/j.joim.2024.06.003 · Cited by 9 · see citing works
Auckley, D. H., Mehra, R., Johnson, K. G., Billings, M. E., Carandang, G., Falck-Ytter, Y. T., Khayat, R., Mustafa, R. A., Peña-Orbea, C., Sahni, A. S., et al. (2025) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.11866 · Cited by 9 · see citing works
Effects of Reflexology on Pain in Patients With Fibromyalgia
Korhan, E. A., Uyar, M., Eyigör, C., Yönt, G. H., & Khorshıd, L. (2016) · Holistic Nursing Practice · doi:10.1097/hnp.0000000000000178 · Cited by 9 · see citing works
McVicar, A. J., Greenwood, C., Ellis, C., & LeForis, C. (2016) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2016.0015 · Cited by 8 · see citing works
El-Solh, A., Lawson, Y., Martinson, A. A., & Wilding, G. E. (2025) · Psychiatric Quarterly · doi:10.1007/s11126-025-10143-9 · Cited by 7 · see citing works
“Assuming a correlation coefficient of 0.7 between pre-and post-treatment [40 ], 21 patients per arm were needed to achieve 80% power at a significance level of 5% in order to detect a clinically significant difference of 3 units in PSQI [ 41].”
InfluentialEvaluation of a tactile breath pacer for sleep problems: A mixed method pilot study
Vermeylen, S., Honinx, E., Broes, S., Vandenhoudt, H., & Witte, N. A. J. D. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2022.908159 · Cited by 7 · see citing works
“The Pittsburgh Sleep Quality Index (PSQI) is a validated self-assessment questionnaire that assesses sleep quality and frontiersin.org FIGURE 1 The Moonbird breath pacer, including a PPG sensor (right picture).”
BackgroundInfluentialBanaei, M., Alizadeh, S., Roozbeh, N., Naz, M. S. G., Taghvaei, E., Parviz, L., & Ghasemi, V. (2025) · BMC Public Health · doi:10.1186/s12889-025-25142-5 · Cited by 6 · see citing works
Mahajan, A., Mahajan, S., & Tilekar, S. D. (2021) · Journal of Aging and Physical Activity · doi:10.1123/japa.2020-0207 · Cited by 6 · see citing works
Shao, C., Lin, L., Chen, M., Wang, N., & Shangguan, W. (2023) · BMC Anesthesiology · doi:10.1186/s12871-023-02109-w · Cited by 6 · see citing works
“The PSQI has a minimum clinically important difference (MCID) of ≥ 3 [18], so we chose 3 scores as the estimated variability between the two groups.”
MethodTakemura, N., Cheung, D. S. T., Fong, D., & Lin, C. (2023) · Palliative & Supportive Care · doi:10.1017/s1478951523000962 · Cited by 6 · see citing works
“We assessed the association of attendance, compliance with home-based practice, and perceived satisfaction with sleep improvement at 4 and 12 months, defined as a change in PSQI that reached the MCID of at least 3 points, through logistic regression.”
Pépin, J., Benjafield, A., Munt, O., Woehrle, H., Heinzer, R. C., Arzt, M. E., & for the READ-ASV Investigators (2025) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.11652 · Cited by 5 · see citing works
“30 The EQ-5D includes 5 items that are each rated from 1 – 5 (1 meaning no problems and 5 meaning severe problems).”
Cognitive behavioural therapy for insomnia in people with cancer
Cai, Z., Tang, Y., Liu, C., Li, H., Zhao, G., Zhao, Z., & Zhang, B. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015176.pub2 · Cited by 6 · see citing works
Teriparatide Plus Zoledronic Acid for Osteogenesis Imperfecta
Hald, J. D., Weir, C. J., Keerie, C., Dewar, L., MacLean, M., Milne, L., Keen, R. W., Walsh, J., Poole, K. E. S., Langdahl, B. L., et al. (2026) · JAMA · doi:10.1001/jama.2026.6889 · Cited by 5 · see citing works
Stavrou, V. T., Vavougyios, G. D., Tsirimona, G., Boutlas, S., Santo, M., Hadjigeorgiou, G. M., Bargiotas, P., & Gourgoulianis, K. I. (2025) · Applied Sciences · doi:10.3390/app15052532 · Cited by 5 · see citing works
Onabotulinumtoxin A Improves Psychological Aspects in Chronic Migraine Patients
Al-Hashel, J., Ashkanani, H. K. A. H. A., Almutairi, O., Bokubar, F., Mubarak, S., Alwazzan, S., Alroughani, R., Youssry, D., & Ahmed, S. F. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2020.633355 · Cited by 5 · see citing works
“On the other hand, a reduction by ≥3-point in the total PSQI score was considered a clinically meaningful improvement (22).”
BackgroundCao, S., Xin, B., Yu, Y., Cheng, P., Zhu, C., Deng, M., Gao, X., Chu, J., & Liu, T. (2023) · World Journal of Surgical Oncology · doi:10.1186/s12957-023-02895-0 · Cited by 5 · see citing works
“Additionally, an improvement in the global PSQI score of ≥ 3 points was considered a minimal clinically important difference [20].”
BackgroundDrozd, C., Curtit, E., Jacquinot, Q., Roux, P., Paget‐Bailly, S., Gillet, V., Méneveau, N., & Mougin, F. (2026) · Breast Cancer Research and Treatment · doi:10.1007/s10549-026-07923-7 · Cited by 4 · see citing works
“For the ISI, PSQI, and MFI-20 questionnaires, a Minimally Clinically Important Difference (MCID) was defined respectively as ≥ 6 points [23], ≥ 3 points [24] and ≥ 2 points.”
Papavero, L., Wilke, J., Ali, N., Schawjinski, K., Holtdirk, A., & Schöller, K. (2024) · Brain and Spine · doi:10.1016/j.bas.2024.102785 · Cited by 4 · see citing works
Peacock, J., Provenzano, D. A., Fishman, M. A., Amirdelfan, K., Bromberg, T. A., Schmidt, T., White, T., Grewal, P. K., Justiz, R., Calodney, A. K., et al. (2024) · Pain Practice · doi:10.1111/papr.13407 · Cited by 4 · see citing works
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Carson, E., Dhillon, H. M., Vardy, J. L., Brown, C. S. B., Nunes-Zlotkowski, K. F., Della‐Fiorentina, S. A., Khan, S. N., Parsonson, A. O., Roncoloato, F., Pearson, A., et al. (2024) · Supportive Care in Cancer · doi:10.1007/s00520-024-08554-8 · Cited by 4 · see citing works
“…more has been recommended as the minimal clinically important difference for the PSQI; therefore an improvement in sleep quality in an individual is defined as a ≥ 3 point decrease in their PSQI total score from baseline to 9 weeks, and deterioration in sleep quality as a ≥ 3 point increase [20].”
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“The minimal important difference in previous literature ranges from 3.0 to 4.4 (Hughes et al., 2009; Longo et al., 2021).”
InfluentialKao, H. S. R., Wang, M., Yu, S., Yuan, S., Fung, M. M. Y., Zhu, L., Lam, S. P. W., Kao, T. T., & Kao, X. (2019) · Chinese Medicine and Culture · doi:10.4103/cmac.cmac_18_19 · Cited by 4 · see citing works
Subramanian, H., Trivedi, R., Fuchsova, V., Elder, E., Brand, A. H., Howle, J. R., Mann, G. J., DeFazio, A., Amis, T. C., & Kairaitis, K. (2023) · Sleep And Breathing · doi:10.1007/s11325-023-02946-6 · Cited by 4 · see citing works
“Clinically meaningful changes in sleep quality over the follow-up period were ascertained by score changes ≥ 3 au (ΔPSQI TOTAL score ≥ 3 au) [17].”
Changes over time in family members of adults with mild traumatic brain injury
Jones, K., Theadom, A., Prah, P., Starkey, N. J., Barker-Collo, S. L., Ameratunga, S. N., Feigin, V. L., & Study, F. T. B. (2019) · Brain Impairment · doi:10.1017/brimp.2019.27 · Cited by 4 · see citing works
“The MCID in a sample of patients with sleep disturbance is –3 (Hughes et al., 2009).”
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Zhao, F.-Y., Zhao, Y.-X., Yan, H., Hong, Y.-F., Ma, Q.-Y., Chen, S.-H., & Xu, H. (2019) · Journal of Acupuncture and Tuina Science · doi:10.1007/s11726-019-1092-0 · Cited by 3 · see citing works
Rapelli, G., Varallo, G., Scarpelli, S., Pietrabissa, G., Musetti, A., Plazzi, G., Franceschini, C., & Castelnuovo, G. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1144087 · Cited by 3 · see citing works
“Interestingly, the total PSQI decreased from the baseline in both follow-ups, meeting the minimal clinically important difference of ≥3 as suggested by previous evidence (Hughes et al., 2009; Eadie et al., 2013; McDonnell et al., 2014; Weinberg et al., 2020).”
BackgroundRahja, M., Laver, K., Mordaunt, D., Adnan, N., Vakulin, A., Lovato, N., & Crotty, M. (2023) · Archives of Rehabilitation Research and Clinical Translation · doi:10.1016/j.arrct.2023.100275 · Cited by 3 · see citing works
Treatment of Insomnia with Comorbid Mental Illness
Tracy, L. (2012) · InTech eBooks · doi:10.5772/32324 · Cited by 3 · see citing works
- Authors
- Hughes, C. M., McCullough, C. A., Bradbury, I., Boyde, C., Hume, D., Yuan, J., Quinn, F., & McDonough, S. M.
- Affiliations
- University of Ulster (GB)
- Health and Rehabilitation Sciences Research Institute, University of Ulster, Ulster, UK
- British Association of Dermatologists (GB)
- Corresponding author
- Hughes, Ciara M
- Venue
- Acupuncture in Medicine
- Publisher
- SAGE Publications
- Published
- 2009-12
- Volume
- 27
- Issue
- 4
- Pages
- 163-168
- ISSN
- 0964-5284 (ISSN-L)
- 1759-9873
- OpenAlex
- W2146381169
- Cited by
- 136
- References
- 24
- Citations by year
- 2026: 3 · 2025: 16 · 2024: 8 · 2023: 24 · 2022: 18 · 2021: 16 · 2020: 10 · 2019: 9 · 2018: 6 · 2017: 2 · 2016: 7 · 2015: 5 · 2014: 4 · 2013: 4 · 2012: 2
- FWCI
- 3.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Acupuncture in Medicine (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Acupuncture Treatment Research Studies
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- acupuncture, reflexology, insomnia, primary insomnia, music therapy, sleep quality, patient recruitment and retention, feasibility, Pittsburgh Sleep Quality Index, SF-36v2, sleep diary
- MeSH terms
- Adult, Combined Modality Therapy, Feasibility Studies, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Massage, Middle Aged, Music Therapy, Surveys and Questionnaires, Sleep, Reproducibility of Results, Acupuncture Therapy, Treatment Outcome
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