1. Home
  2. Approved trials
  3. » فارسی

Determining the effect of ear acupressure on the severity and occurrence of constipation and related quality of life during the pregnancy: A Double-Blind, Randomized Controlled Trial

Protocol summary

Study aim
Determining the effect of ear acupressure on the amount and severity of constipation and the quality of life related to it in pregnant women with constipation during pregnancy
Design
The clinical trial has an intervention and a control group, with parallel, double-blind and randomized groups, which will be conducted on 144 patients
Settings and conduct
This research will be conducted on pregnant women suffering from pregnancy constipation who refer to the prenatal center of Nohe-Day Hospital and Health Center in Torbat-E-Heydarieh. The participants are divided into two study groups using the random block method with blocks of size 4. In this study, the participants and the researcher will be blind as well.
Participants/Inclusion and exclusion criteria
Pregnant women aged 18-25 years; singleton pregnancy with normal and live embryo; wanted pregnancy; pregnancy constipation background based on ROME III index; being literate in reading and writing. Exclusion criteria: suffering from chronic constipation; digestive disorders; skin disease; infection and local lesion in the ear; recent use of pharmaceutical or non-pharmacological methods to reduce constipation; smoking
Intervention groups
Intervention group: In this group, effective points on constipation during pregnancy are stimulated by magnetic seeds using ear acupressure. These seeds remain in place for 7 days and are pressed by the person 8 times a day. Control group: ear acupressure will be performed in sham points for 7 days.
Main outcome variables
Constipation rate; severity of constipation; Quality of life-related to constipation, bristol stool form scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190625044009N2
Registration date: 2024-04-19, 1403/01/31
Registration timing: prospective

Last update: 2024-04-19, 1403/01/31
Update count: 0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Mahla Rajabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 6795
Email address
rajabzadehm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of ear acupressure on the severity and occurrence of constipation and related quality of life during the pregnancy: A Double-Blind, Randomized Controlled Trial
Public title
The effectiveness of ear acupressure on constipation and quality of life in pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-35 years at any gestational age A singleton pregnancy with a normal and live embryo Wanted pregnancy Pregnancy constipation background based on the ROME III index Literacy No record of chronic constipation and digestive disorders, such as irritable bowel syndrome, anal fissure, rectal prolapse, intestinal obstruction and skin disease No record of infection and local lesion in the ear area No recent use of pharmaceutical or non-pharmacological methods to reduce constipation Not record of active or passive smoking
Exclusion criteria:
Suffering from chronic constipation, requiring medicine interventions (e.g., emollient, cassia, fig, hedge mustard, and Fusion herbal syrup) Digestive disorders, such as irritable bowel syndrome Psychological treatment history (medicine and mental treatment)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design with a size of 4 was used for randomization. A total number of 36 blocks of four were prepared. Then, the samples were assigned to intervention and control groups. A specific letter is assigned to each group to construct the allocation sequence (A: Intervention Group, B: control Group). The allocation sequence will then be generated using online methods (https://www.sealedenvelope.com/simple-randomiser/v1/lists) without individual intervention. Next, the sequence is written on the sheets and placed in sealed envelopes, respectively to conceal the allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random sequence will be provided to the main researcher and then based on the created sequence; each participant will be assigned to a particular group. Then, they will be placed in envelopes designed for this purpose, and each envelope will be numbered and closed. The person who is responsible for the implementation of the study will open the envelopes based on the number assigned to the patients and will perform the intervention based on the respective group. The person who is responsible for conducting the study is unaware of the type of intervention in the control and intervention groups. Since this intervention is performed in sham points for the control group, the patients are not informed of the nature of the allocated group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 604, 6th floor, central building of Tehran University of Medical Sciences, intersection of Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-10, 1402/01/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.023

Health conditions studied

1

Description of health condition studied
Constipation in pregnancy
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
severity and occurence of Constipation
Timepoint
At the beginning of the study (before the intervention) and 7 days after the intervention
Method of measurement
Using the Constipation Assessment Scale for Pregnancy

2

Description
stool form
Timepoint
Before the intervention and during the intervention after each round of defecation is recorded
Method of measurement
Using the bristol stool form scale

Secondary outcomes

1

Description
Constipation quality of life
Timepoint
At the beginning of the study (before the intervention) and 7 days after the intervention
Method of measurement
Using the Constipation Quality of Life Scale

Intervention groups

1

Description
Intervention group: Both external earlobes are first cleaned with 75% alcohol, then the points of the rectum, large intestine, spleen, Shen Men and Senjia are determined and a magnetic seed is placed by the researcher in each point. Then the researcher teaches the patients to press the seeds 8 times a day for one minute each time. Pressing the points should be continued until they feel tingling or slight discomfort hese seeds remain in the constipation control points for 7 days and then removed
Category
Treatment - Other

2

Description
Control group: Both external earlobes are first cleaned with 75% alcohol; then, the points of vision, knee joint, eye, and shoulder joint (which do not have any effect on constipation) are determined. A magnetic seed is placed by the researcher in each point. Then, the researcher teaches the patients to press the seeds 8 times a day for one minute each time. Pressing should be continued until they feel tingling or slight discomfort. These seeds should remain in the constipation control points for 7 days and then removed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
9th Day hospital
Full name of responsible person
Zahra Nikfarjam
Street address
Kashani Avenue, Torbat Heydariyeh
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
3116695188
Phone
+98 51 5222 6016
Email
rajabzadehm951@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Tehran 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mahla Rajabzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Torbat Heydarieh University of Medical Sciences, Razi St., Torbat Heydarieh
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Phone
+98 51 5222 9202
Email
rajabzadehm951@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mahla Rajabzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Torbat Heydarieh University of Medical Sciences, Razi St., Torbat Heydarieh
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Phone
+98 51 5222 9202
Email
rajabzadehm951@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mahla Rajabzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Torbat Heydarieh University of Medical Sciences, Razi St., Torbat Heydarieh
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Phone
+98 51 5222 9202
Email
Rajabzadehm951@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Currently, no decision has been made in this regard by the team
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...