Protocol summary

Summary
The aim of this study is to determine the effect of acupressure on anxiety, self-efficacy and pregnancy in infertile women undergoing intracytoplasmic sperm insemination (ICSI) and explain their understanding and experience from this treatment. This mix method study consisted of two stages that the first part is a clinical trial. The sample size is 144 infertile women. Inclusion criteria include female infertility, primary infertility, undergoing treatment ICSI, no history of mental illness and, age between 20 to 45 years. Exclusion criteria are: stressful events during study for participants, no participation in more than 2 of intervention sessions. Then, the Beck Anxiety Inventory (Beck) is completed by them. People with severe anxiety are excluded. The questionnaires consisted of infertility self-efficacy and social support perceived questions are completed by people who entered study. The subjects are randomly divided into three groups: sham and real acupressure and control groups. Patients receive acupressure treatment three times a week for 4 weeks with ICSI. The control group will receive only ICSI treatments. Acupressure is performed until a day before the embryo transfer. Again after intervention, questionnaires are completed in three groups. An employee outside the research team will complete the questionnaires with aim of blinding or masking the study group assignment. Data analysis is done by consulting statistics. Finally, β HCG hormone assay is performed to determine pregnancy in three groups, 15 days after embryo transfer. In this study, major variables are including anxiety, self-efficacy and pregnancy rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506072924N2
Registration date: 2015-12-15, 1394/09/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-15, 1394/09/24
Registrant information
Name
Maryam Hassanzadeh Bashtian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 1206
Email address
m.h.bashtian@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, mashhad University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Assessing the effects of acupressure on anxiety, self-efficacy, and pregnancy rate in the infertile women undergoing intra cytoplasmic sperm insemination (ICSI) and description of their perception and experience of this treatment
Public title
Effect of acupressure on th self-efficacy, anxiety and pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian native, female infertility, primary infertility, undergoing treatment ICSI, no history of mental illness, age between 20 to 45 years, do not take anti-anxiety and anti-depressant medications, no history of use of acupressure, and acupressure is not performed during this study for other diseases. Exclusion criteria: stressful events during study for participants, abnormal uterine cavity, severe anxiety, no participation in more than 2 of intervention sessions, without desire to continue to participate in the study
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the groups allocation is used from Fleiss randomization table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Mashhad University of Medical Sciences
Street address
Across 18, Daneshgah street, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.MUMS.REC.1394.313

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
female infertility

Primary outcomes

1

Description
Anxiety. self-efficacy. social support
Timepoint
Before intervention. Immediately after intervention end
Method of measurement
Beck anxiety inventory. infertility self-efficacy questionnaire Cousineau. social support questionnaire Zimet

Secondary outcomes

1

Description
pregnancy rate
Timepoint
Almost one month after intervention end
Method of measurement
B HcG test

Intervention groups

1

Description
Acupressure is done by a researcher for the subjects at the HT7 and PC6 points. Each point is pressed in the both hands for three minutes.Acupressure is done three times in the week for 4 weeks.
Category
Other

2

Description
Sham group:In the sham group, the misplaced points that are in two cm from main areas are used for acupressure.
Category
Other

3

Description
control group not receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad IVF center
Full name of responsible person
Maryam Hassanzadeh Bashtian
Street address
School of Nursing and midwifery, Doktora intersection, Daneshgah Street.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Voice research.Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3589 1511
Fax
Email
hasanzadehbm911@mums.ac.ir; m.h.bashtian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
PhD candidate in reproductive health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
hasanzadehbm911@mums.ac.ir; m.h.bashtian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medicla Sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
PhD candidate in reproductive health
Other areas of specialty/work
Street address
School of nursing and midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
m.h.bashtian@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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