Protocol summary

Study aim
Compare effects of muscle relaxation and acupressure on anxiety severity in patients undergoing coronary angiography
Design
A total of 90 patients undergoing angiography were recruited for this double-blind, randomized, parallel-group clinical trial. Participants were allocated to two intervention groups and one control group via a color-coded randomization technique.
Settings and conduct
Patients who were candidates for coronary angiography at Ali Ibn Abi Taleb (AS) Hospital in Zahedan were randomly assigned to three groups. After recording baseline vital signs and anxiety levels, the first intervention group underwent muscle relaxation four times daily, and the second group received P6 acupressure four times daily. The control group received routine care. Finally, vital signs and anxiety levels were reassessed.
Participants/Inclusion and exclusion criteria
Ages 18-65 Verbal communication ability Coronary angiography candidate Full consciousness
Intervention groups
Muscle Relaxation Group: Participants completed four 20-minute sessions of progressive muscle relaxation (at 18:00, 23:00, 06:00, and pre-angiography). Patients were guided to progressively relax muscles from feet to face, close their eyes, and concentrate on breath (nasal inhalation, slow oral exhalation) while silently repeating a calming word. They were encouraged to disregard disruptive thoughts and let relaxation unfold naturally. Acupressure Group: Bilateral acupressure was applied to the P6 point (three finger-widths proximal to the wrist crease) at 18:00, 23:00, 06:00, and pre-angiography. Each session involved 3 minutes of continuous circular thumb pressure (3–5 kg at two revolutions per second) to induce mild numbness or tingling, followed by a 2-minute rest. Control Group: This group received standard ward care without additional interventions.
Main outcome variables
Patients' anxiety level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181028041484N4
Registration date: 2026-07-12, 1405/04/21
Registration timing: prospective

Last update: 2026-07-12, 1405/04/21
Update count: 0
Registration date
2026-07-12, 1405/04/21
Registrant information
Name
Aliakbar Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
aliakbar.keykha@zaums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-21, 1405/04/30
Expected recruitment end date
2027-11-21, 1406/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Muscle Relaxation and Acupressure on Anxiety in Patients Undergoing Coronary Angiography
Public title
Comparison of Muscle Relaxation and Acupressure on Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18-65 Verbal communication ability Coronary angiography candidate Full consciousness
Exclusion criteria:
Traumatic chest injury Open-heart surgery history History of psychiatric disorders Hearing and vision impairment Taking antipsychotics and sleeping pills
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomized into three parallel groups (muscle relaxation, acupressure, and control) in a 1:1:1 ratio. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes containing colored cards (red, green, and white, respectively). An independent researcher, not involved in the recruitment or assessment process, prepared the allocation sequence. Participants were blinded to the assignment mechanism until after the envelope was opened and assignment was finalized.
Blinding (investigator's opinion)
Double blinded
Blinding description
To ensure blinding, vital signs were measured and anxiety questionnaires were administered by a trained nurse who was blinded to the group allocation (control vs. intervention). Furthermore, data were anonymized through a coding system prior to SPSS entry, preventing the statistical analyst from identifying the participants’ group assignments.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Doctor hesabi Square, Persian golf Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2025-03-02, 1403/12/12
Ethics committee reference number
IR.ZAUMS.REC.1403.473

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Patients' anxiety level
Timepoint
Pre- and post-intervention
Method of measurement
Spielberger Anxiety Inventory (StAI)

2

Description
Patients' vital signs
Timepoint
Pre- and post-intervention
Method of measurement
Sadat Company's bedside monitoring.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The muscle relaxation was administered four times daily (at 18:00, 23:00, 06:00, and immediately prior to angiography), with each session lasting 20 minutes. Patients were instructed to assume a comfortable position, close their eyes, and perform progressive muscle relaxation from the feet to the face. This was coupled with focused breathing (nasal inhalation and slow oral exhalation) and the silent repetition of a calming word. Additionally, patients were encouraged to disregard intrusive thoughts and allow the relaxation process to occur spontaneously.
Category
Treatment - Other

2

Description
Intervention group: Acupressure was applied bilaterally to the P6 point (three finger-widths proximal to the wrist crease). Using the thumb, circular pressure was applied at a rate of two rotations per second, with an intensity ranging from 3 to 5 kg. This intervention was administered in four daily sessions (at 18:00, 23:00, 06:00, and immediately prior to angiography). Each session consisted of 3 minutes of continuous pressure—applied until the patient reported a mild sensation of numbness—followed by a 2-minute rest period.
Category
Treatment - Other

3

Description
Control group: This group received standard ward care without additional interventions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital (AS) Zahedan
Full name of responsible person
Aliakbar Keykha
Street address
Ali ibn Abitaleb Hospital, KHalige Fars Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
aliakbar.keykha@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansari Moghaddam
Street address
Zahedan, Persian Gulf Blvd., Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
zaums.research@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir Square, School of Nursing and Midwifey, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
aliakhbar.kheykha@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir Square, School of Nursing and Midwifey, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
aliakhbar.kheykha@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aliakbar Keykha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir Square, School of Nursing and Midwifey, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
aliakhbar.kheykha@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data of patients are collected without personal information and sent to other researchers by email upon request.
When the data will become available and for how long
It is possible to send patients' information after the publication of the article of this project (end of 2026).
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The use of data for research and therapeutic purposes is authorized in accordance with institutional ethical guidelines.
From where data/document is obtainable
Faculty of Nursing and Midwifery, Behdasht Blv, Zahedan aliakbar.keykha@zaums.ac.ir or aliakbar.keykha@gmail.com
What processes are involved for a request to access data/document
To access the information, you must first send your request to me via email. After receiving the request, I will make the necessary arrangements with the Vice President of Research and Technology of Zahedan University of Medical Sciences and if there is no legal prohibition, I will send the data to you via email.
Comments
Loading...