Protocol summary

Study aim
The effects of acupressure at points SP6, PC6, and HT7 on sleep quality, anxiety, and physiological indicators in patients with heart failure will be investigated.
Design
A randomized controlled clinical trial with parallel groups, conducted on 76 patients from a convenience sample.
Settings and conduct
Patients with heart failure referred to Farshchian Educational and Medical Center in Hamadan and Imam Hossein Hospital in Malayer will be randomly assigned to intervention and control groups. For the acupressure intervention, patients will be positioned appropriately, and pressure will be applied gradually and rhythmically with the fingertips at points SP6, PC6, and HT7. The researcher will identify the exact points and apply pressure in a controlled, rhythmic manner, sufficient for participants to feel warmth, heaviness, or numbness in the target area without causing physical discomfort.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Willingness to participate in the study; 2) Signing the informed consent form; 3) Diagnosed heart failure (EF < 40%); 4) Ability to speak and understand Persian. Exclusion criteria: 1) Addiction to alcohol, illicit drugs, or sedative medications; 2) Known speech, hearing, or cognitive impairments; 3) Use of sedative or anti-anxiety medications within the past 24 hours
Intervention groups
Intervention group: Patients in the intervention group will receive acupressure at points SP6, PC6, and HT7 twice daily, 30 minutes per session, for three consecutive days. Control group: Patients in the control group will receive superficial pressure at neutral points surrounding the main points, following the same protocol as the intervention group. Primary outcomes: Sleep quality, anxiety levels, and physiological indicators will be assessed in both groups.
Main outcome variables
Sleep quality, anxiety levels, and physiological indicators

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190524043687N6
Registration date: 2025-12-19, 1404/09/28
Registration timing: prospective

Last update: 2025-12-19, 1404/09/28
Update count: 0
Registration date
2025-12-19, 1404/09/28
Registrant information
Name
Ali Safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 5861 5962
Email address
asafdari.nu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-31, 1404/10/10
Expected recruitment end date
2026-04-30, 1405/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effects of Acupressure on Sleep Quality, Anxiety, and Physiological Indicators in Patients with Heart Failure
Public title
Investigating the Effects of Acupressure on Sleep Quality, Anxiety, and Physiological Indicators in Patients with Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to Participate in the Study Signing of Informed Consent Form Ability to speak and understand the Persian language Diagnosed heart failure (EF < 40%), as confirmed by the treating physician
Exclusion criteria:
Presence of conditions such as intellectual disability, mental or behavioral disorders, hearing impairment, or speech disorders Presence of a previously diagnosed psychiatric disorder and/or sleep disorder Use of complementary therapies prior to the study Presence of addiction to alcohol, illicit drugs, or sedative medications Use of sedative or anti-anxiety medications within the past 24 hours Presence of any contraindication at the pressure application site (e.g., wounds, skin diseases, etc.)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated in equal numbers to the intervention and control groups using block randomization. To ensure the unpredictability of group assignment, allocation concealment will be performed by a statistical collaborator, and the randomization sequence will remain concealed until the time of intervention. For this purpose, opaque, sealed, and sequentially numbered envelopes containing the random allocation sequence will be used. Accordingly, after generating an appropriate random sequence based on the method described above and according to the study sample size, a number of opaque envelopes will be prepared. Each randomly generated sequence will be recorded on a card, and the cards will be placed sequentially inside the envelopes. To preserve the random sequence, the envelopes will be numbered consecutively on their outer surface. Finally, the envelopes will be sealed and placed in order inside a box. At the start of participant enrollment, based on the order in which eligible participants enter the study, one envelope will be opened sequentially, and the group assignment for that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, clinical caregivers, outcome assessors, and the statistical collaborator will be blinded to the allocation of patients to the intervention and control groups. The research collaborator responsible for outcome assessment will conduct evaluations without knowledge of participants’ group assignments. To maintain blinding during data analysis, study data will be provided to the statistical collaborator in a coded format (A: intervention group, B: control group), without revealing the actual group identities. To assess the effectiveness of blinding, at the end of the intervention period, participants will be asked to guess the group to which they were assigned (intervention or control). The success of blinding will then be evaluated and reported by comparing the guesses between groups using appropriate statistical tests.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2025-12-13, 1404/09/22
Ethics committee reference number
IR.UMSHA.REC.1404.769

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Sleep Quality
Timepoint
Before the start of the study and on the second, third, and fourth days of hospitalization
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

2

Description
Anxiety
Timepoint
Spielberger Anxiety Questionnaire
Method of measurement
Before, immediately after, and 30 minutes after the daily intervention

3

Description
Arterial oxygen saturation
Timepoint
Before, immediately after, and 30 minutes after the daily intervention
Method of measurement
Pulse oximetry

4

Description
Systolic blood pressure
Timepoint
Before, immediately after, and 30 minutes after the intervention
Method of measurement
Digital sphygmomanometer

5

Description
Diastolic blood pressure
Timepoint
Before, immediately after, and 30 minutes after the intervention
Method of measurement
Digital sphygmomanometer

6

Description
Heart rate
Timepoint
Before, immediately after, and 30 minutes after the intervention
Method of measurement
Pulse oximetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Patients with heart failure in the intervention group will first complete questionnaires assessing sleep quality and anxiety, and their physiological parameters, including systolic and diastolic blood pressure, heart rate, respiratory rate, and arterial oxygen saturation, will be measured. Then, acupressure will be applied at SP6, PC6, and HT7 points by a trained researcher. Patients will be positioned in a quiet environment with minimal noise, light, and temperature distractions, and their privacy will be maintained. The researcher will locate the precise points and gradually apply fingertip pressure in a smooth, rhythmic manner until participants report sensations of warmth, heaviness, or numbness in the targeted area without experiencing physical discomfort. This intervention will be performed twice daily, each session lasting 30 minutes, over three consecutive days. After each session, questionnaires and physiological parameters will be reassessed and recorded. To ensure the accuracy of the acupressure protocol and compliance with standard guidelines for acupressure and acupuncture research, a pilot study will be conducted prior to the main trial. Findings from this preliminary study will guide the timing of outcome measurements and finalize the intervention protocol, including session duration and frequency.
Category
Other

2

Description
Control Group: Patients in this group will first complete questionnaires assessing sleep quality and anxiety. Their physiological parameters, including systolic and diastolic blood pressure, heart rate, respiratory rate, and arterial oxygen saturation, will also be measured. Then, to maintain procedural consistency and blinding, they will receive gentle, superficial pressure at neutral points surrounding the main acupressure sites, following the same protocol as the intervention group. After each session, the questionnaires and physiological parameters will be reassessed and recorded.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart and Vascular Subspecialty Educational and Treatment Center
Full name of responsible person
Ali Afshari
Street address
Farshchian Heart and Vascular Subspecialty Educational and Treatment Center, Shahid Fahmideh Blvd., Chahar Rah-e Pazhouhesh, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir

2

Recruitment center
Name of recruitment center
Imam Hossein Hospital, Malayer
Full name of responsible person
Ali Elmtaleb
Street address
Imam Hossein Hospital, Parastar Blvd., Malayer
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3222 0001
Fax
Email
imamhosseinhospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
3869865178
Phone
+98 81 3838 0535
Email
soltanian@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
Ali Afshari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
afshari777@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Afshari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Fax
Email
afshari777@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
asafdari.nu@gmail.com

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
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