to determine the effect of head massage on the level of preoperative anxiety in patients who are candidates for elective cesarean surgery
Design
A clinical trial with a control group, with parallel groups, a blind strain, randomized, on 72 pregnant women, Random software was used for randomization.
Settings and conduct
This study will be conducted in the gynecological surgery department of Behbahan public hospitals by a researcher and supervised by a physiotherapist.
Participants/Inclusion and exclusion criteria
enter:
1. Elective cesarean surgery with indication
2. 16 years old
3. Minimum reading and writing literacy
4. Pregnancy age 34 weeks and above
5. Not having a history of anxiety and mental illness according to self-report
6. Not taking self-reported anti-anxiety and sedative drugs
Failure to enter:
1. Unwillingness of the participant
2. Failure to complete the questionnaire
3. Having diseases related to turning
4. Any condition that leads to increased anxiety and the need for an emergency cesarean section.
Intervention groups
It is done 1 hour before transferring the pregnant woman to the operating room in the gynecological surgery department of the research environment. Before each intervention, the demographic questionnaire and the Spielberger anxiety questionnaire will be completed by the patients; Then, for the intervention group, in addition to the usual hospital care, the patient is placed in a comfortable position, then by the researcher and under the supervision of the physiotherapist to perform the standard head massage, the massage without gloves is performed with 5 ml of turquoise baby oil for 30 minutes. The control group receives only usual hospital care. They complete the questionnaire one hour before the operation and then 20 minutes before transfer to the operating room.
Main outcome variables
The level of anxiety before cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240311061255N1
Registration date:2024-03-18, 1402/12/28
Registration timing:prospective
Last update:2024-03-18, 1402/12/28
Update count:0
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Zahra Padam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5235 0273
Email address
zpadam21@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of head massage on the preoperative anxiety in women candidates for elective caesarean section
Public title
Investigating the effect of head massage on the preoperative anxiety in women candidates for elective caesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Elective caesarean section surgery (due to diagnosis like previous caesarean section, some medical diseases, incompatibility of the cesarean section with the mother's pelvis, abnormal position of the fetus such as breech position, triplets and above, twins in cases of non-cephaly of the first or second trimester)
2. People over 16 years old
3. Having minimum reading and writing literacy
4. Having an indication of termination of pregnancy at a gestational age of 34 weeks and above
5. Not having a history of heart and mental illness according to self-report
6. Not taking anti-anxiety and sedative drugs according to self-report
Exclusion criteria:
1. Unwillingness of the participants
2. Failure to complete the questionnaire
3. Having diseases related to turning
4. Any situation that leads to increased anxiety and the need for an emergency cesarean section; such as bleeding and rupture of the amniotic sac.
Age
From 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Women candidates for elective caesarean section who meet the study entry criteria and sign the informed consent form will enter the study and will be randomly assigned to two intervention and control groups using the Random Allocation Software (48) version 9/4. . Random allocation by permutation blocks is listed in 9 blocks of 8 with Random Allocation software; The list provided is attached to the proposal.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present research will be a randomized clinical trial study of a blind (blindness of statistical analysis).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz School of Nursing and Midwifery
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH),entrance of Namazi Hospital, Namazi Square ,Shiraz Town
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.155
Health conditions studied
1
Description of health condition studied
Anxiety before cesarean section of pregnant women
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Spielberger questionnaire anxiety score
Timepoint
1 hour before surgery, 20 minutes before surgery
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Anxiety score after head massage
Timepoint
1 hour before surgery, 20 minutes before surgery (after head massage)
Method of measurement
Spielberger anxiety questionnaire
Intervention groups
1
Description
Intervention group: A 30-minute head massage session according to the head massage technique in the basic article, which is applied one hour before transferring the patient from the gynecological surgery department to the operating room. This means that in addition to the usual hospital care, head massage is also performed for this group by the researcher according to the mentioned method.
Category
Treatment - Other
2
Description
Control group: This group receives only the usual hospital care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faride Behbahani Hospital of Behbahan
Full name of responsible person
Zahra Padam
Street address
Faridah Behbahani Hospital, Shahid Abdullahi Alley, Fermandari Street, Behbahan City
City
Behbahan
Province
Khouzestan
Postal code
6361911111
Phone
+98 61 5272 2072
Email
zpadam21@gmail.com
2
Recruitment center
Name of recruitment center
Social Security Hospital of Behbahan.
Full name of responsible person
Zahra Padam
Street address
Mustafa Khomeini Hospital, Koi Hojjat Ibn Al-Hassan, Behbahan City
City
Behbahan
Province
Khouzestan
Postal code
6361844744
Phone
+98 61 5283 2008
Email
zpadam21@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand St., Central Organization of Shiraz University of Medical Sciences, Research and Technology Vice-Chancellor, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2710
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Jamshid Eslami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Dr. Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatimah (PBUH), Shiraz Town
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
jam_eslami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Padam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Shahid Mousavi Nesab Ave, Behbahan Town
City
Behbahan
Province
Khouzestan
Postal code
6361844744
Phone
+98 61 5283 2008
Email
zpadam21@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Padam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Shahid Mousavi Nesab Ave, Amirpoya Blvd, Behbahan Town
City
Behbahan
Province
Khouzestan
Postal code
6361844744
Phone
+98 61 5283 2008
Email
zpadam21@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