Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05904405
Other study ID # quality of family planning
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2023
Est. completion date September 2024

Study information

Verified date June 2023
Source Assiut University
Contact Samah Ali
Phone 01100698745
Email samah.ali69@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 423
Est. completion date September 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: -reproductive aged women (either adapter, continuer, and switcher) and seeking FB services (last counseling session) Exclusion Criteria: - Women who do not meet the above criteria will be excluded from the present study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
quationaire
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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) .
one year
See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Completed NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Active, not recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A