Quality of Life
Conditions
Keywords
LARC
Brief summary
assessment of quality of life in women using LARC
Detailed description
The ability to control one's fertility is a cornerstone of reproductive health and personal autonomy, fundamentally influencing women's educational, economic, and social trajectories. Modern contraception provides this control, offering a diverse range of methods that allow women and couples to plan if and when to have children. The choice of contraceptive method is a deeply personal decision, often guided by a complex interplay of medical history, lifestyle, personal values, and an individual's priorities regarding efficacy, convenience, and potential side effects (Bangar & Bansal, 2023). Long-Acting Reversible Contraception (LARC) emerged as a highly effective and increasingly popular category. LARC methods are distinguished by their requirement for administration by a healthcare provider but offer protection against pregnancy for an extended period, ranging from three to ten years, without any ongoing user action. Their "forget-and-forget" nature eliminates the need for daily, weekly, or monthly adherence, resulting in typical-use effectiveness rates that rival those of permanent sterilization. (Francis et al., 2024). While the clinical effectiveness of LARC in preventing pregnancy is well-established, a comprehensive understanding of its impact must extend beyond this singular outcome to encompass the broader concept of quality of life (QoL). Quality of life is a multidimensional construct that includes physical well-being, psychological state, social relationships, and environmental factors. For a woman using contraception, QoL is affected not only by her confidence in avoiding an unintended pregnancy but also by her experience with method-related side effects (such as changes in bleeding patterns, mood, or weight), the convenience of use, and the overall sense of control over her reproductive health. (Alsammani & Ahmed, 2023)
Interventions
DEVICEEtonogestrel Implant
Insertion of a single etonogestrel-releasing subdermal contraceptive implant in the upper arm by a trained healthcare provider according to standard clinical practice.
Insertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception.
Insertion of a copper intrauterine device into the uterine cavity by a trained healthcare provider as a non-hormonal long-acting contraceptive method.
Sponsors
Assiut University
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* women aged 18 to 45 years, women used LARC contraception, women agreed to participate.
Exclusion criteria
* women using non LARC contraception, women had any psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score at 3 Months Post-Method Initiation | Baseline and 3 months after contraceptive method initiation | Assessment of quality of life using the WHOQOL-BREF, a 26-item questionnaire with four domains (physical health, psychological well-being, social relationships, environmental factors). Raw domain scores are transformed to a 0-100 scale using the formula: \[(raw score - lowest possible)/range\] × 100. Scale range: 0 to 100 per domain; higher scores indicate better quality of life. Primary analysis will compare mean change in overall QoL score from baseline to 3 months between LARC and non-LARC groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Reporting Dysmenorrhea Assessed by Visual Analogue Scale (VAS) for Pain | Baseline and 3 months after method initiation | Dysmenorrhea incidence defined as VAS score ≥1/10 at 3-month follow-up. Scale: Visual Analogue Scale (VAS), 0 cm = "no pain" to 10 cm = "worst imaginable pain." Reporting: Percentage of participants with VAS ≥1 (binary outcome: yes/no). |
| Mean Dysmenorrhea Severity Score Assessed by Visual Analogue Scale (VAS) | Baseline and 3 months after method initiation | Dysmenorrhea incidence defined as VAS score ≥1/10 at 3-month follow-up. Scale: Visual Analogue Scale (VAS), 0 cm = "no pain" to 10 cm = "worst imaginable pain." Reporting: Percentage of participants with VAS ≥1 (binary outcome: yes/no). |
| Change in Female Sexual Function Index (FSFI) Total Score | Baseline and 3 months after method initiation | FSFI is a 19-item questionnaire across six domains (desire, arousal, lubrication, orgasm, satisfaction, pain). Scale range: Total score 2 to 36; higher scores indicate better sexual function. Sexual dysfunction defined as total score ≤26.55. Reporting: Mean change in FSFI total score from baseline to 3 months; domain scores reported separately if clinically relevant. |
| Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21) | Baseline and 3 months after method initiation | DASS-21 depression subscale: 7 items, each rated 0-3; raw sum doubled to align with DASS-42 metric. Scale range: 0 to 42; higher scores indicate worse depressive symptoms. Severity cutoffs: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+). Reporting: Mean change in depression score; proportion exceeding clinical cutoffs |
Contacts
CONTACTAya Mohamed, master
STUDY_DIRECTORElwani Elderemy, Professor
Assiut University
STUDY_DIRECTORMansour Ahmed, Professor
Assiut University
STUDY_DIRECTORAbdelrahman Mahmoud, lecturer
Assiut University
Outcome results
None listed