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Investigating the effect of of Psycho-spiritual approach in improving sexual performance, sleep quality and depression in women with type 2 diabetes: randomized clinical trial

Protocol summary

Study aim
Determining the effect of the psycho-spiritual approach in improving sexual function, sleep quality, and depression in women with type 2 diabetes
Design
The clinical trial, with parallel groups, single-blind, randomized, on 60 patients, will be used for randomization from https://www.sealedenvelpe.com.
Settings and conduct
This research will be done at Alborz Shahid Rajaei Hospital. Before the implementation of the intervention, the level of sexual performance, sleep quality, and depression of the participants will be filled by the relevant questionnaires. Then, the intervention will be done in the intervention group, and immediately after the end of the intervention, and 3 months after the intervention, the questionnaires will be completed again in both groups.
Participants/Inclusion and exclusion criteria
Entering criteria: married women aged 18 to 45 with type 2 diabetes, diagnosis of diabetes by a doctor and at least one year of diabetes diagnosis, being interested in participating in the study, and not having a mental disability including any kind of mental or cognitive disorder that hinders participation in the process of mutual interaction, adherence to the program, or giving informed consent to participate in this study, having a Farsi dialect Exclusion criteria: participation in unusual educational programs or similar research while conducting research, inability to continue participating in the study, and Failure to participate in all meetings
Intervention groups
In the control group, routine care will be done. In the intervention group, for 10 weeks, a 45-90 minute session with a psycho-spiritual approach will be conducted by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and in a group.
Main outcome variables
Sexual performance; Sleep quality; Depression

General information

Reason for update
Acronym
PSA (Psycho-Spiritual Approach)
IRCT registration information
IRCT registration number: IRCT20220704055367N2
Registration date: 2022-09-10, 1401/06/19
Registration timing: prospective

Last update: 2022-09-10, 1401/06/19
Update count: 0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Fatemeh Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
fatemeh.abdi87@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of of Psycho-spiritual approach in improving sexual performance, sleep quality and depression in women with type 2 diabetes: randomized clinical trial
Public title
The effect of Psycho-spiritual approach in women with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18 to 45 with type 2 diabetes Diagnosed with diabetes by a doctor and at least one year has passed since the diagnosis of diabetes Being interested in participating in the study Not having mental incompetence, including any kind of mental or cognitive disorder that prevents participation in the interaction process, adherence to the program, or giving informed consent to participate in this study Having Persian dialect
Exclusion criteria:
Participating in unusual educational programs or similar research while conducting research Inability to continue participating in the study for any reason (need for special care, immigration, death) Failure to participate in all meetings
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to select the sample, after preparing a list of type 2 diabetes patients who referred to the diabetes clinic of Shahid Rajaei Alborz Hospital, they will be contacted. Then, 60 people who wish to participate in the research will be selected using available sampling and will be included in the study based on the criteria for entering the research. And they will be randomly assigned to two groups of psycho-spiritual approach and control, each of which will have 30 participants. In order to randomize the samples, the block randomization method, which is a limited randomization method related to studies with groups with the same sample size, will be used. Also, in this study, according to the sample size, two blocks of 30 will be considered. In order to implement this method, jerrydallal.com/random/assign.htm will be used. And on the mentioned site, the title of the two groups (psycho-spiritual intervention and control), the number of blocks, and the volume of each block will be mentioned. Then, according to the randomization obtained from the site and the last three numbers of the patients' files, randomization will be done. In this way, in the face of the obtained randomizations, we will write down the last three numbers of the patients' files in order from the least to the most, and according to that, the patients in each of the control groups and the psycho-spiritual approach They will be.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers. Also, it will be specified with one of the English letters above it, which questionnaire was completed by the participants of which of the study groups; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Alborz University of Medical Sciences
Street address
Ethics committee office, Second floor, Safarian alley, 45 meters to Golshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-08-12, 1401/05/21
Ethics committee reference number
IR.ABZUMS.REC.1401.119

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Sexual performance scores on Female Sexual Function Index
Timepoint
Measurement of women's sexual performance scores at the beginning of the study, 10 weeks later, 22 weeks later
Method of measurement
Female Sexual Function Index

2

Description
Sleep quality scores in the Pittsburgh Sleep Quality Index
Timepoint
Measurement of sleep quality score at the beginning of the study, 10 weeks later, 22 weeks later
Method of measurement
Pittsburgh Sleep Quality Index

3

Description
Depression scores in Beck depression Inventory
Timepoint
Measurement of depression score at the beginning of the study, 10 weeks later, 22 weeks later
Method of measurement
Beck Depression Inventory

4

Description
Patient's treatment compliance
Timepoint
Measurement of treatment compliance score at the beginning of the study, 10 weeks later, 22 weeks later
Method of measurement
Morisky Medication Adherence Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: It will be formed in the intervention group in order to create group coordination in WhatsApp. Group meetings will be held in groups of 30 people. In order to implement the psycho-spiritual approach in the intervention group, 10 sessions of 45-90 minutes each week will be held by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and with the coordination of patients in a group. Considering that the conditions of diabetic patients are special, it is difficult for them to participate in face-to-face classes. Therefore, they may not be able to participate in the class in person. In addition, if they gather in one place for training, some diseases may be transmitted and become a problem. Therefore, according to the mentioned cases, it was preferred that the training be virtual, but still, a decision will be made according to the conditions of the patients in this field. The spiritual approach is written by using the content of the chapter on spiritual methods to relieve the pain of patients from the book of spiritual care. Dr. Mino Asadzandi, a member of the academic faculty of the Baqiyatullah University of Medical Sciences and the Medicine and Religion Research Center, will be implemented. Also, the psychological approach will be implemented using the content of the group psychotherapy book (theoretical and practical basics) by Yalom and Lashech translated by Mahshid Yasai. The first session is for familiarization and introduction, sessions 2 to 4 are designed for a spiritual approach, and sessions 5 to 10 will be designed for a psychological approach.
Category
Treatment - Other

2

Description
Control group: The control group will receive usual care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Karaj educational and therapeutic center
Full name of responsible person
Fatemeh Abdi
Street address
Shahid Rajaei St, Hesarak
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Email
rajaei@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Alborz Univeirsity of Medical Sciences (ABZUMS), Northern Taleghani boulevard,Taleghani square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6007
Email
fatemeh.abdi87@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Taleghani Boulevard,Taleghani square, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3419 7000
Email
fatemeh.abdi87@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6007
Email
fatemeh.abdi87@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
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome and general demographic information can be shared.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
Doctors, nurses, midwives, researchers working in universities and medical centers and hospitals, clinical psychologists
Under which criteria data/document could be used
In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published
From where data/document is obtainable
Communication through e-mail (if possible to share information from a legal and ethical point of view, such as sharing the primary outcome of the study) To receive information, contact the following email address: fatemeh.abdi87@yahoo.com In the case of sending letter with regard to the current study, the following postal address of the corresponding author is available: School of nursing, Eshteraki street, Takhti Park, Baghestan BLVD
What processes are involved for a request to access data/document
Finding the responsible author's email, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester.
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