ContraceptionNCT05904405
Perceived Quality of Family Planning Counselling
An observational study of Contraception, run by Assiut University.
Trial summary
The goal of this cross sectional study is to test Perceived quality of family planning counseling and its determinants among females in reproductive age in El-Dakhla District, New Valley government ,Egypt. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- quationaire
- How many people
- 423 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Sep 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: There are 18 primary health care centers and one general hospital in El-Dakhla District, New Valley. The target population will be selected from the general hospital and primary health centers of El-Dakhla District. The number of women chosen in each primary health center and the main hospital will be proportional to the number of women served by the facility until reaching the estimated sample size. The questionnaire will be distributed by the researcher herself to all women of the selected centers except those who refuse to participate in the study.
Who may be able to join
- -reproductive aged women (either adapter, continuer, and switcher) and seeking FB services (last counseling session)
Who cannot join
- Women who do not meet the above criteria will be excluded from the present study.
Trial locations and contacts
No sites are listed yet.
Doaa Mazen, doctorate contact
About this study
Official title: Perceived Quality of Family Planning Counseling and Its Determinants Among Reproductive Aged Women in El-dakhla District, New Valley Government,Egypt
The goal of this cross sectional study is to test Perceived quality of family planning counseling and its determinants among females in reproductive age in El-Dakhla District, New Valley government ,Egypt.
The main question[s] it aims to answer are:
- During the contraception consultation, I was able to give my opinion about what I needed.
- I received complete information about my options for contraceptive methods.
- The provider knew how to explain contraception clearly.
- I had the opportunity to participate in the selection of a method.
- I received information about how to protect myself from sexually transmitted infections.
- I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed).
- I could understand how my body might react to using contraception.
- I could understand how to use the method(s) we talked about during the consultation.
- I received information about what to do if I wanted to stop using a method.
- The provider explained to me what to do if I had a reaction to a method (e.g., allergies, nausea, pains, menstrual changes).
- I felt the information I shared with the provider was going to stay between us.
- The provider gave me the time I needed to consider the contraceptive options we discussed.
- The provider was friendly during the contraception consultation.
- I felt the health care provider had sufficient knowledge about contraceptive methods.
- The provider showed interest in my health while we talked about contraception.
- The provider was interested in my opinions.
- I felt listened to by the provider
- The provider pressured me to use the method they wanted me to use.
- I felt the provider treated me poorly because they tend to judge people.
- I felt scolded because of my age.
- The provider made me feel uncomfortable because of my sex life (e.g., when I started having sex, my sexual preferences, the number of partners I have, the number of children I have).
- The provider looked at me or touched me in a way that made me feel uncomfortable.
Read the detailed description
In 2017, Holt, Dehlendorf, and Langer created a framework for contraceptive counseling quality grounded in quality of care and human rights principles and research in healthcare communication.
Based on this framework, Holt et al. developed and validated the Quality of Contraceptive Counseling (QCC) Scale, which covers three interrelated aspects of counseling quality: information exchange, interpersonal relationship, and disrespect and abuse . The scale comprehensively measures aspects of the counseling process related not only to information receipt but also individuals' experiences having the opportunity to participate in the method selection process and the degree to which they had positive and trusting experiences with the provider .
Associations between quality of contraceptive counseling and characteristics of clients, such as age, education, and reproductive status, could represent significant health disparities and indicate the need for research. This study will seek to understand quality of family planning counseling utilizing the validated and client-centered based QCC Scale as experienced by reproductive aged women in El-Dakhla District, New Valley. Furthermore, it will investigate their associated factors either client, provider, or visit factors.
Data collection tool
Data will be collected through a semi-structured interview administered questionnaire which includes:
- Socio-demographic characteristics of women such as age, education, occupation, religion, residence, husband's education, husband's occupation.
- Family planning practice: This will include number of living children, current use of FP method and its type, and suggested causes of discontinuation of FP, previous contraceptive use, and reason for the visit
3-Facility factors such as gender of providers, qualification of providers, type of the health facility (mobile clinics???) 4-Quality of contraceptive counseling (QCC) scale: it is a 22-item scale which measures the quality of care received by women during family planning visits. It includes : 1) information exchange, 2) interpersonal relations, and 3) disrespect and abuse in contraceptive counseling. The information exchange subscale consists of ten items, the interpersonal relationship subscale consists of seven items, and the disrespect and abuse subscale consists of five items. Item responses were given on four-point Likert scales. Response categories for positively worded items were "completely agree" (4), "agree" (3), "disagree" (2), and "completely disagree" (1). Response categories for negatively worded items were "yes" (1), "yes with doubts" (2), "no with doubts" (3), and "no" (4). Composite subscale and total scores were calculated as mean scores .
Items of QCC scale:
Information exchange factor
- During the contraception consultation, I was able to give my opinion about what I needed.
- I received complete information about my options for contraceptive methods.
- The provider knew how to explain contraception clearly.
- I had the opportunity to participate in the selection of a method.
- I received information about how to protect myself from sexually transmitted infections.
- I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed).
- I could understand how my body might react to using contraception.
- I could understand how to use the method(s) we talked about during the consultation.
- I received information about what to do if I wanted to stop using a method.
- The provider explained to me what to do if I had a reaction to a method (e.g., allergies, nausea, pains, menstrual changes). Interpersonal relationship factor
- I felt the information I shared with the provider was going to stay between us.
- The provider gave me the time I needed to consider the contraceptive options we discussed.
- The provider was friendly during the contraception consultation.
- I felt the health care provider had sufficient knowledge about contraceptive methods.
- The provider showed interest in my health while we talked about contraception.
- The provider was interested in my opinions.
- I felt listened to by the provider Response Options: Completely agree - 4 Agree - 3 Disagree - 2 Completely disagree - 1 Disrespect and abuse factor
- The provider pressured me to use the method they wanted me to use.
- I felt the provider treated me poorly because they tend to judge people.
- I felt scolded because of my age.
- The provider made me feel uncomfortable because of my sex life (e.g., when I started having sex, my sexual preferences, the number of partners I have, the number of children I have).
- The provider looked at me or touched me in a way that made me feel uncomfortable.
Response Options:
Yes - 1 Yes with doubts - 2 No with doubts - 3 No - 4
Scoring Procedures:
Scores from the individual items are used to calculate a composite score using a simple mean, with higher scores indicating higher reported quality of services
Statistical analysis Data entry and analysis will be carried out using SPSS version 24. Descriptive statistics will be done in the form of frequencies, mean and SD then analytic statistics will be done as chi square, independent sample test and correlations tests. Values will be considered significant when P values are equal to or less than 0.05.
Pilot study
Before starting to collect data, a pilot study will be carried out to fulfill the following purposes:
- Testing the questionnaire form and detecting any modification required.
- Estimation of the time needed to fill the questionnaire.
- Detection of the difficulties that may arise and how to deal with them. Implications of the study Results of proposed study will be disseminated to stakeholders to help in planning paper interventions to improve quality of family planning services in El-Dakhla District, New Valley
Ethical Considerations
- The research proposal will be reviewed and approved by the Ethical Committee of Assiut Faculty of Medicine.
- Administrative permission will be obtained from Directorate of health affairs in New Valley Governrate.
- Informed written consent will be obtained from subjects before being included in the study.
- Privacy and confidentiality of the data will be assured.
- Conditions
- Contraception
- Being tested
- quationaire
- Keywords
- Counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quationaireOther
Data will be collected through a semi-structured interview administered questionnaire which includes:
- Socio-demographic characteristics of women
- Family planning practice: This will include number of living children, current use of FP method and its type, and suggested causes of discontinuation of FP, previous contraceptive use, and reason for the visit 3-Facility factors such as gender of providers, qualification of providers, type of the health facility.
4-Quality of contraceptive counseling (QCC) scale: it is a 22-item scale which measures the quality of care received by women during family planning visits. It includes : 1) information exchange, 2) interpersonal relations, and 3) disrespect and abuse in contraceptive counseling. The information exchange subscale consists of ten items, the interpersonal relationship subscale consists of seven items, and the disrespect and abuse subscale consists of five items.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of family planning counseling in family planning services, among reproductive aged women in El-Dakhla District, New Valley governorate .
Client reported quality of family planning counseling at family planning services and its determinants among 423 women at reproductive age in El-Dakhla District, New Valley. at different primary health centers of El-Dakhla District and El-Dakhla general hospital.
By using questionnaire QCC Scale (quality of contraceptive counseling scale) .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 423 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Ali Ezzat Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904405
- Sponsor's protocol ID
- quality of family planning
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Quality of Family Planning Counseling and Its Determinants Among Reproductive Aged Women in El-dakhla District, New Valley Government,Egypt
- ClinicalTrials.gov ID
- NCT05904405
- Acronym / sponsor ID
- quality of family planning
- Conditions
- Contraception
- Keywords
- Counselling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cross sectional study is to test Perceived quality of family planning counseling and its determinants among females in reproductive age in El-Dakhla District, New Valley government ,Egypt.
The main question[s] it aims to answer are:
- During the contraception consultation, I was able to give my opinion about what I needed.
- I received complete information about my options for contraceptive methods.
- The provider knew how to explain contraception clearly.
- I had the opportunity to participate in the selection of a method.
- I received information about how to protect myself from sexually transmitted infections.
- I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed).
- I could understand how my body might react to using contraception.
- I could understand how to use the method(s) we talked about during the consultation.
- I received information about what to do if I wanted to stop using a method.
- The provider explained to me what to do if I had a reaction to a method (e.g., allergies, nausea, pains, menstrual changes).
- I felt the information I shared with the provider was going to stay between us.
- The provider gave me the time I needed to consider the contraceptive options we discussed.
- The provider was friendly during the contraception consultation.
- I felt the health care provider had sufficient knowledge about contraceptive methods.
- The provider showed interest in my health while we talked about contraception.
- The provider was interested in my opinions.
- I felt listened to by the provider
- The provider pressured me to use the method they wanted me to use.
- I felt the provider treated me poorly because they tend to judge people.
- I felt scolded because of my age.
- The provider made me feel uncomfortable because of my sex life (e.g., when I started having sex, my sexual preferences, the number of partners I have, the number of children I have).
- The provider looked at me or touched me in a way that made me feel uncomfortable.
Detailed description
In 2017, Holt, Dehlendorf, and Langer created a framework for contraceptive counseling quality grounded in quality of care and human rights principles and research in healthcare communication.
Based on this framework, Holt et al. developed and validated the Quality of Contraceptive Counseling (QCC) Scale, which covers three interrelated aspects of counseling quality: information exchange, interpersonal relationship, and disrespect and abuse . The scale comprehensively measures aspects of the counseling process related not only to information receipt but also individuals' experiences having the opportunity to participate in the method selection process and the degree to which they had positive and trusting experiences with the provider .
Associations between quality of contraceptive counseling and characteristics of clients, such as age, education, and reproductive status, could represent significant health disparities and indicate the need for research. This study will seek to understand quality of family planning counseling utilizing the validated and client-centered based QCC Scale as experienced by reproductive aged women in El-Dakhla District, New Valley. Furthermore, it will investigate their associated factors either client, provider, or visit factors.
Data collection tool
Data will be collected through a semi-structured interview administered questionnaire which includes:
- Socio-demographic characteristics of women such as age, education, occupation, religion, residence, husband's education, husband's occupation.
- Family planning practice: This will include number of living children, current use of FP method and its type, and suggested causes of discontinuation of FP, previous contraceptive use, and reason for the visit
3-Facility factors such as gender of providers, qualification of providers, type of the health facility (mobile clinics???) 4-Quality of contraceptive counseling (QCC) scale: it is a 22-item scale which measures the quality of care received by women during family planning visits. It includes : 1) information exchange, 2) interpersonal relations, and 3) disrespect and abuse in contraceptive counseling. The information exchange subscale consists of ten items, the interpersonal relationship subscale consists of seven items, and the disrespect and abuse subscale consists of five items. Item responses were given on four-point Likert scales. Response categories for positively worded items were "completely agree" (4), "agree" (3), "disagree" (2), and "completely disagree" (1). Response categories for negatively worded items were "yes" (1), "yes with doubts" (2), "no with doubts" (3), and "no" (4). Composite subscale and total scores were calculated as mean scores .
Items of QCC scale:
Information exchange factor
- During the contraception consultation, I was able to give my opinion about what I needed.
- I received complete information about my options for contraceptive methods.
- The provider knew how to explain contraception clearly.
- I had the opportunity to participate in the selection of a method.
- I received information about how to protect myself from sexually transmitted infections.
- I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed).
- I could understand how my body might react to using contraception.
- I could understand how to use the method(s) we talked about during the consultation.
- I received information about what to do if I wanted to stop using a method.
- The provider explained to me what to do if I had a reaction to a method (e.g., allergies, nausea, pains, menstrual changes). Interpersonal relationship factor
- I felt the information I shared with the provider was going to stay between us.
- The provider gave me the time I needed to consider the contraceptive options we discussed.
- The provider was friendly during the contraception consultation.
- I felt the health care provider had sufficient knowledge about contraceptive methods.
- The provider showed interest in my health while we talked about contraception.
- The provider was interested in my opinions.
- I felt listened to by the provider Response Options: Completely agree - 4 Agree - 3 Disagree - 2 Completely disagree - 1 Disrespect and abuse factor
- The provider pressured me to use the method they wanted me to use.
- I felt the provider treated me poorly because they tend to judge people.
- I felt scolded because of my age.
- The provider made me feel uncomfortable because of my sex life (e.g., when I started having sex, my sexual preferences, the number of partners I have, the number of children I have).
- The provider looked at me or touched me in a way that made me feel uncomfortable.
Response Options:
Yes - 1 Yes with doubts - 2 No with doubts - 3 No - 4
Scoring Procedures:
Scores from the individual items are used to calculate a composite score using a simple mean, with higher scores indicating higher reported quality of services
Statistical analysis Data entry and analysis will be carried out using SPSS version 24. Descriptive statistics will be done in the form of frequencies, mean and SD then analytic statistics will be done as chi square, independent sample test and correlations tests. Values will be considered significant when P values are equal to or less than 0.05.
Pilot study
Before starting to collect data, a pilot study will be carried out to fulfill the following purposes:
- Testing the questionnaire form and detecting any modification required.
- Estimation of the time needed to fill the questionnaire.
- Detection of the difficulties that may arise and how to deal with them. Implications of the study Results of proposed study will be disseminated to stakeholders to help in planning paper interventions to improve quality of family planning services in El-Dakhla District, New Valley
Ethical Considerations
- The research proposal will be reviewed and approved by the Ethical Committee of Assiut Faculty of Medicine.
- Administrative permission will be obtained from Directorate of health affairs in New Valley Governrate.
- Informed written consent will be obtained from subjects before being included in the study.
- Privacy and confidentiality of the data will be assured.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- There are 18 primary health care centers and one general hospital in El-Dakhla District, New Valley. The target population will be selected from the general hospital and primary health centers of El-Dakhla District. The number of women chosen in each primary health center and the main hospital will be proportional to the number of women served by the facility until reaching the estimated sample size. The questionnaire will be distributed by the researcher herself to all women of the selected centers except those who refuse to participate in the study.
Key inclusion criteria (1 listed)
- -reproductive aged women (either adapter, continuer, and switcher) and seeking FB services (last counseling session)
Key exclusion criteria (1 listed)
- Women who do not meet the above criteria will be excluded from the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quationaireData will be collected through a semi-structured interview administered questionnaire which includes: 1. Socio-demographic characteristics of women 2. Family planning practice: This will include number of living children, current use of FP method and its type, and suggested causes of discontinuation of FP, previous contraceptive use, and reason for the visit 3-Facility factors such as gender of providers, qualification of providers, type of the health facility. 4-Quality of contraceptive counseling (QCC) scale: it is a 22-item scale which measures the quality of care received by women during family planning visits. It includes : 1) information exchange, 2) interpersonal relations, and 3) disrespect and abuse in contraceptive counseling. The information exchange subscale consists of ten items, the interpersonal relationship subscale consists of seven items, and the disrespect and abuse subscale consists of five items. | Other | – |
Primary outcome
Quality of family planning counseling in family planning services, among reproductive aged women in El-Dakhla District, New Valley governorate .
Time frame: one year
Client reported quality of family planning counseling at family planning services and its determinants among 423 women at reproductive age in El-Dakhla District, New Valley. at different primary health centers of El-Dakhla District and El-Dakhla general hospital. By using questionnaire QCC Scale (quality of contraceptive counseling scale) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- 1\. World Health Organization (WHO). WHO Definition of Family Planning-Public Health. 2020. p. Available at: https:// www.publichealth.com.ng/who.Link provided by the sponsor.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Mazen, doctorate contact
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samah Ali (01100698745, samah.ali69@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of family planning counseling in family planning services, among reproductive aged women in El-Dakhla District, New Valley governorate . (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.