The effect of Hugo point massage on body pain and fatigue in patients with brucellosis admitted to the infectious disease ward of Sina Hospital, Hamadan.
Evaluating the Effect of Hegu Point Massage on Body Pain and Fatigue in Hospitalized Patients with Brucellosis in the Infectious Diseases Ward of Sina Hospital, Hamadan
Design
A three-arm parallel-group trial , randomized, single-blind, conducted in 174 patients; randomization was performed using sealed envelopes.
Settings and conduct
Study setting
Infectious Diseases Ward, Sina Hospital, Hamedan.
Procedures
Participants randomized to intervention, control, or sham; baseline and follow-up questionnaires; intervention per allocation.
Blinding
Single-blind: participants blinded to group assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
To be under a doctor's supervision for all patients
To be literate in reading and writing in order to complete the questionnaire
To be aged 18 and above
Exclusion criteria:
To have a history of mental disorders based on the patient's medical records
To participate in pain reduction programs of other studies
To take painkillers other than the ward's routine medication
To have a skin lesion at the site of acupressure application
To be unwilling to continue cooperation
To develop a serious physical problem
To receive less than four sessions of training
Intervention groups
Intervention Group 1: Acupressure at the Hegu point plus routine care.
Intervention Group 2: Acupressure at a non‑Hegu site plus routine care.
Control Group: Routine care only, no acupressure.
Pressure increased over 30 seconds until tingling, maintained with constant thumb pressure for 1 minute, then released over 30 seconds. Protocol: three 5‑minute cycles with 2‑minute rests, intermittently, up to 20 minutes total.
Main outcome variables
Score on the NRS questionnaire (Numeric Rating Scale for pain assessment)
Score on the Multidimensional Fatigue Inventory (MFI) questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250927067381N1
Registration date:2025-10-15, 1404/07/23
Registration timing:prospective
Last update:2025-10-15, 1404/07/23
Update count:0
Registration date
2025-10-15, 1404/07/23
Registrant information
Name
Reza Rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3830 2243
Email address
r.rabiei@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-06-22, 1405/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hugo point massage on body pain and fatigue in patients with brucellosis admitted to the infectious disease ward of Sina Hospital, Hamadan.
Public title
The effect of Hugo point massage on body pain and fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
To be under a doctor's supervision for all patients
To be literate in reading and writing in order to complete the questionnaire
To be aged 18 and above
Exclusion criteria:
To have a history of mental disorders based on the patient's medical records
To participate in pain reduction programs of other studies
To take painkillers other than the ward's routine medication
To have a skin lesion at the site of acupressure application
To be unwilling to continue cooperation
To develop a serious physical problem
To receive less than four sessions of training
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
174
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will first be selected via convenience sampling and randomly assigned in a crossover design to one of three groups: Group A (pressure applied at the Hugo point), Group B (pressure applied at a sham point), and Group C (control). Randomization will be carried out using permuted blocks of three; specifically, the sequences BCA, ABC, BAC, CAB, CBA, BAC, and ACB will be written on slips of paper and placed into sealed envelopes. Upon obtaining informed consent, each patient will select one envelope and be allocated to the corresponding group according to the letter sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization was carried out using permuted blocks of three. The block sequences BCA, ABC, BAC, CAB, CBA, BAC, and ACB were written on paper and placed in sealed envelopes. After obtaining informed consent, each participant selected one envelope; assignment to the corresponding group followed the order indicated by the letters. Participants remained unaware of their group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Office of Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences (UMSHA), Building No. 4, Shariati Crossroad., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۸۴
Approval date
2025-09-20, 1404/06/29
Ethics committee reference number
IR.UMSHA.REC.1404.494
Health conditions studied
1
Description of health condition studied
brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Score on the NRS questionnaire (Numeric Rating Scale for pain assessment)
Timepoint
To complete the Numeric Rating Scale (NRS) before and after the intervention
Method of measurement
Numeric Rating Scale (NRS)
2
Description
Score on the Multidimensional Fatigue Inventory (MFI) questionnaire
Timepoint
To complete the Multidimensional Fatigue Inventory (MFI) before and after the intervention
Method of measurement
Multidimensional Fatigue Inventory (MFI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: In this group, in addition to routine post-treatment care, the Hegu point is first identified. A gentle pressure massage is then applied for 30 seconds, with the pressure gradually increased until the participant experiences tingling, numbness, heaviness, and a sensation of stretching in the surrounding area. The thumb is maintained on the point for 1 minute; subsequently, the pressure is progressively released over 30 seconds to fully release the point. Each intervention cycle lasts 5 minutes.The massage is administered intermittently for a maximum of 20 minutes, comprising three 5-minute massage sessions separated by 2-minute rest intervals (i.e., 5 minutes of massage followed by 2 minutes of rest, repeated until the 20-minute limit is reached).
Category
Treatment - Other
2
Description
Intervention Group 2: In this group, in addition to routine post-treatment care, pressure massage is applied to a point located outside the Hegu point as follows. First, gentle pressure is exerted on the non-Hegu point for 30 seconds, with the force gradually increased until the participant experiences pronounced tingling, numbness, heaviness, and a sensation of stretching in the surrounding area. Next, the thumb remains in place for 1 minute; thereafter, the pressure is progressively released over 30 seconds to fully release the point. The entire intervention cycle lasts 5 minutes.The massage is administered intermittently for a maximum total of 20 minutes, consisting of three 5-minute massage sessions separated by 2-minute rest intervals (i.e., 5 minutes of massage followed by 2 minutes of rest, repeated until the 20-minute limit is reached).
Category
Treatment - Other
3
Description
Control Group: In this group, no acupressure therapy will be administered, and participants will receive only routine post-treatment care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Reza Rabiei
Street address
Unit 7, Building No. 9 Sepehrdad, Arghavan Street, Beheshti Town
City
Hamadan
Province
Hamadan
Postal code
6514894294
Phone
+98 81 3830 2243
Email
r.rabiei@edu.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Office of Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences (UMSHA), Building No. 4, Shariati Crossroad., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۸۴
Phone
+98 81 3131 4058
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Rabiei
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6514894294
Phone
+98 81 3830 2243
Fax
Email
r.rabiei@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezo Karamporian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 7250
Fax
Email
a.karampourian@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Rabiei
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6514894294
Phone
+98 81 3830 2243
Fax
Email
r.rabiei@edu.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available