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The Effect of Acupressure on Pain Severity, Anxiety, and Vital Sign in Patients with Renal Colic Referring to the Emergency Department

Protocol summary

Study aim
Determination of the Effect of Acupressure on Pain Intensity, Anxiety, and Vital Signs in Patients with Renal Colic Presenting to the Emergency Department
Design
A randomized, parallel-group, controlled clinical trial, open-label, phase 3, including 100 patients. Randomization was performed using a number table.
Settings and conduct
The study will be conducted in the Emergency Department of LabafiNejad Hospital. Eligible patients, after providing informed consent, will be assigned to the intervention or control group. Interventions will be applied according to the defined protocol, and data on pain intensity, anxiety, and vital signs will be collected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed renal colic diagnosis, age 18–65 years, full consciousness (GCS=15), mild to moderate pain (VAS 3–6). Exclusion criteria: Voluntary withdrawal, history of abdominal or genitourinary surgery, need for hospitalization or treatments outside the study protocol, lack of continuous cooperation with study procedures.
Intervention groups
Intervention group: The intervention group will receive combined acupressure on the Qiu point along the bladder meridian and routine pharmacological treatment. Acupressure will be performed by a trained researcher in three 1-minute sessions with 30-second rests. The procedure will be stopped if the patient experiences discomfort. Control group: The control group will receive routine emergency care, including pharmacological pain relief, without any additional interventions.
Main outcome variables
Pain intensity; Anxiety level; Vital signs including pulse rate, blood pressure and respiratory rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250802066727N1
Registration date: 2025-11-05, 1404/08/14
Registration timing: registered_while_recruiting

Last update: 2025-11-05, 1404/08/14
Update count: 0
Registration date
2025-11-05, 1404/08/14
Registrant information
Name
Zahra Mojallal Qarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 511 4996
Email address
zahra.mojallal@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-10-20, 1404/07/28
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Pain Severity, Anxiety, and Vital Sign in Patients with Renal Colic Referring to the Emergency Department
Public title
The Effect of Acupressure on Pain Severity, Anxiety, and Vital Sign in Patients with Renal Colic Referring to the Emergency Department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of renal colic by the emergency department physician Age between 18 and 65 years Full consciousness (Glasgow Coma Scale score = 15) Pain intensity at the time of enrollment ranging from mild to moderate, with a score of 3 to 6 on the Visual Analogue Scale (VAS)
Exclusion criteria:
Voluntary withdrawal from participation at any stage of the study History of abdominal or genitourinary surgery Need for emergency hospitalization or receiving specialized treatments outside the study protocol Lack of consistent cooperation with the study instructions and requirements
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
After confirming the inclusion criteria, eligible participants will be randomly assigned into two groups using simple randomization. For this purpose, each participant will be assigned a number generated by a random number table or statistical software such as SPSS. The participants’ names will be recorded in the order of their entry into the study, and the corresponding numbers will be extracted from the table. Even numbers will be assigned to the intervention group (combined acupressure and pharmacological method), and odd numbers will be assigned to the control group (routine pharmacological method). To ensure allocation concealment, the group assignments of each participant will be placed in sealed, opaque envelopes prepared and numbered by an individual who is not a member of the research team. The allocation ratio in this study will be 1:1.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculties of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of
Street address
Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2025-10-20, 1404/07/28
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1404.163

Health conditions studied

1

Description of health condition studied
Acute renal colic pain in patients referred to the emergency department
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic

Primary outcomes

1

Description
Pain intensity measured by the Visual Analogue Scale (VAS)
Timepoint
before the intervention, 15 minutes, and 30 minutes after the intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Anxiety level measured by the Spielberger State-Trait Anxiety Inventory (STAI-S)
Timepoint
before the intervention, 15 minutes, and 30 minutes after the intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory

2

Description
Vital signs including pulse rate, respiratory rate, blood pressure
Timepoint
before the intervention, 15 minutes, and 30 minutes after the intervention
Method of measurement
Blood pressure will be measured using a digital sphygmomanometer, radial pulse rate will be counted manually, and respiratory rate will be recorded by observing chest movements.

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive a combined intervention of acupressure and pharmacological treatment. Acupressure will be performed by a trained and qualified researcher on the Qiu point (corresponding to BL-23 in Traditional Chinese Medicine) along the bladder meridian in the lumbar region. The patient will lie on the side with the painful area on top. Acupressure will be applied using the thumb or index finger gradually, uniformly, and continuously, with a tolerable pressure. The procedure consists of three 1-minute pressure sessions with 30-second rests in between, totaling approximately 5 minutes. The researcher will monitor patient tolerance continuously, and the procedure will be stopped immediately if the patient feels discomfort or wishes to discontinue. Simultaneously, participants will receive the routine pharmacological pain relief according to the emergency department protocol
Category
Treatment - Other

2

Description
Control group: Participants in the control group will receive routine emergency care including pharmacological pain relief according to the emergency department protocol, without any additional interventions such as acupressure or other non-pharmacological methods.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Labbafinejad Hospital
Full name of responsible person
Fatemeh Hasan Doost
Street address
Pasdaran, Paydarfar St., Corner of 9th Boostan
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2254 9011
Email
info@sbmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjoo Blvd., Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Hasan Doost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
021 88655366-70
Email
fateme_hd_66@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Hasan Doost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
021 88655366-70
Fax
+98 21 8865 5363
Email
fateme_hd_66@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Hasan Doost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Highway, in front of Shahid Rajaei Heart Hospital, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
021 88655366-70
Email
fateme_hd_66@yahoo.com

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be shared in a coded form, ensuring the confidentiality of participants’ names and personal information.
When the data will become available and for how long
Start of access period after results publication
To whom data/document is available
Researchers affiliated with academic and scientific institutions
Under which criteria data/document could be used
For further investigations, addressing study limitations, and use in clinical practice
From where data/document is obtainable
Dr. Fatemeh Hasan Doost fateme_hd_66@yahoo.com
What processes are involved for a request to access data/document
After sending an email to the author, the required data will be provided while respecting intellectual property rights.
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