CClinicalTrials.gg
Not yet recruitingNCT05904405Updated Jun 15, 2023

Perceived Quality of Family Planning Counselling

An observational study in Contraception, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
423
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. During the contraception consultation, I was able to give my opinion about what I needed.
  2. I received complete information about my options for contraceptive methods.
  3. The provider knew how to explain contraception clearly.
  4. I had the opportunity to participate in the selection of a method.
  5. I received information about how to protect myself from sexually transmitted infections.
  6. I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed).
  7. I could understand how my body might react to using contraception.
  8. I could understand how to use the method(s) we talked about during the consultation.
  9. I received information about what to do if I wanted to stop using a method.
  10. The provider explained to me what to do if I had a reaction to a method (e.g., allergies, nausea, pains, menstrual changes).
  11. I felt the information I shared with the provider was going to stay between us.
  12. The provider gave me the time I needed to consider the contraceptive options we discussed.
  13. The provider was friendly during the contraception consultation.
  14. I felt the health care provider had sufficient knowledge about contraceptive methods.
  15. The provider showed interest in my health while we talked about contraception.
  16. The provider was interested in my opinions.
  17. I felt listened to by the provider
  18. The provider pressured me to use the method they wanted me to use.
  19. I felt the provider treated me poorly because they tend to judge people.
  20. I felt scolded because of my age.
  21. 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).
  22. 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:

  1. Socio-demographic characteristics of women such as age, education, occupation, religion, residence, husband's education, husband's occupation.
  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 (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

  1. During the contraception consultation, I was able to give my opinion about what I needed.
  2. I received complete information about my options for contraceptive methods.
  3. The provider knew how to explain contraception clearly.
  4. I had the opportunity to participate in the selection of a method.
  5. I received information about how to protect myself from sexually transmitted infections.
  6. I received information about what to do if a method fails (e.g., broken condom, forget a pill, feel an IUD is poorly placed).
  7. I could understand how my body might react to using contraception.
  8. I could understand how to use the method(s) we talked about during the consultation.
  9. I received information about what to do if I wanted to stop using a method.
  10. 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

  11. I felt the information I shared with the provider was going to stay between us.
  12. The provider gave me the time I needed to consider the contraceptive options we discussed.
  13. The provider was friendly during the contraception consultation.
  14. I felt the health care provider had sufficient knowledge about contraceptive methods.
  15. The provider showed interest in my health while we talked about contraception.
  16. The provider was interested in my opinions.
  17. I felt listened to by the provider

    Response Options:

    Completely agree - 4 Agree - 3 Disagree - 2 Completely disagree - 1 Disrespect and abuse factor

  18. The provider pressured me to use the method they wanted me to use.
  19. I felt the provider treated me poorly because they tend to judge people.
  20. I felt scolded because of my age.
  21. 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).
  22. 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:

  1. Testing the questionnaire form and detecting any modification required.
  2. Estimation of the time needed to fill the questionnaire.
  3. 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

  1. The research proposal will be reviewed and approved by the Ethical Committee of Assiut Faculty of Medicine.
  2. Administrative permission will be obtained from Directorate of health affairs in New Valley Governrate.
  3. Informed written consent will be obtained from subjects before being included in the study.
  4. Privacy and confidentiality of the data will be assured.
02

Conditions studied

  • Contraception

Keywords

  • Counselling
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

-reproductive aged women (either adapter, continuer, and switcher) and seeking FB services (last counseling session)

Exclusion criteria

Exclusion Criteria:

  • Women who do not meet the above criteria will be excluded from the present study.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
423 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Otherquationaire

    Data 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.

06

What researchers measure

Primary outcomes

  1. 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) .

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05904405
Lead sponsor
Assiut University
Responsible party
Samah Ali Ezzat Mahmoud (Assistant Specialest at Obstetrics and Gynecology Department,Eldakhla General Hospital,New Valley Governorat. ., Assiut University) — Principal investigator
First posted
Jun 15, 2023
Start date
Jul 2023 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 15, 2023

Study contacts

Samah Ali
Contact
samah.ali69@med.aun.edu.eg
01100698745
Doaa Mazen, doctorate
Contact
01027044477

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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