Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:28 PM
Study NCT ID:
NCT07459894
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levine's Conservation Model-Based Nursing Care
Sponsor:
Fayoum University
Organization:
Study Overview
Official Title:
Levine's Conservation Model-Based Nursing Care: A Framework for Enhancing Psychological Adaptation, Perception, and Social Support in Infertile Women: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Infertility is a significant health problem, and the prevalence of infertility is increasing in developing countries. The WHO estimates that 8%-10% of married women experience difficulties in becoming pregnant. While many women who experience infertility can become pregnant through assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF). IVF treatment can result in various psychological-emotional consequences, including stress, anxiety, depression, and hopelessness. This study aimed to evaluate the effect of nursing care based-levin's conservative model on psychological adaptation, perception and perceived social support in infertile women. Study design was a randomized controlled trial (RCT) research design. The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University, that allocated in Menoufia Governorate, Egypt. The study sample was a purposive sample of 80 infertile women attended the previously mentioned settings and was divided equally into study and control group (40 women). Four tools were used for data collection: A structured interviewing questionnaire, psychological adaptation tools, infertility perception scale for women (IPS-W and the multidimensional perceived social support scale.
Detailed Description:
Introduction Infertility is one of the most common chronic diseases among people of childbearing age. Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. affecting roughly 8% to 12% of reproductive-aged couples worldwide, the worldwide prevalence of involuntary childlessness varies between 52.6 and 200 million couples, the majority being residents of low- and middle-income countries (LMICs). Infertility can be primary or secondary. Primary infertility is when a pregnancy has never been achieved by a person, and secondary infertility is when at least one prior pregnancy has been achieved. Infertility may occur due to male, female or unexplained factors. Some causes of infertility are preventable. Treatment of infertility often involves in-vitro fertilization (IVF) and other types of medically assisted reproduction.
Despite of recent data on infertility globally are lacking, it has been estimated that 48 million couples and 186 million individuals worldwide live with infertility. Additionally, 12% of Egyptian couples have infertility, according to research by the Egyptian Fertility Care Society that was funded by the World Health Organization (WHO). 7.7% of them experience secondary infertility, while 4.3% experience main infertility.
Through the application of Levine's Conservation Model, the study highlights the vital role of nurses in promoting holistic adaptation and resilience during infertility treatment. Moreover, the outcomes can inform policy development and clinical guidelines that prioritize comprehensive, patient-centered care, thereby ensuring that infertile women receive not only medical treatment but also the emotional and social support necessary to thrive.
Aim The present study aims to evaluate the effect of nursing care based on Levine's Conservation Model on psychological adaptation, perception and perceived social support in infertile women. Research Hypotheses
1. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher perception scores post-intervention than women who receive routine care.
2. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher psychological adaptation scores post-intervention than women who receive routine care.
3. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher social support scores post-intervention than women who receive routine care.
Method Research Design A randomized controlled trial (RCT) research design was employed to examine the effect of nursing care based on Levine's Conservation Model on perception, psychological adaptation, and perceived social support among infertile women undergoing infertility treatment. This design was chosen because it is the most rigorous method of determining whether a cause-effect relationship exists between an intervention and outcome.
Study Setting The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University, that allocated in Menoufia Governorate, Egypt. It is a specialized outpatient clinic that provides diagnostic and therapeutic services for couples experiencing infertility. The setting was selected because it attracts a large number of women with primary and secondary infertility, thus providing an adequate sampling frame for the research studies.
A purposive sample of 80 diagnosed infertile women was selected from outpatient clinic according to the inclusion criteria. Each woman was allocated to either the intervention or control group through a coin toss conducted by the researcher. Due to some women are dropped out, recruitment continued until both groups reached the required sample size. If the coin toss directed a new woman to a group that had already reached its target number, that woman was not enrolled, and the researcher continued tossing the coin until a woman was assigned to the group that still needed members. This procedure was repeated until the intended number for both groups was fulfilled. They were divided into two equal groups: Group I (experimental group), composed of 40 women, educational conservation nursing intervention in addition to their medication regimen, while group II (control group), composed of 40 women received their medication regimen only. To avoid contamination between groups, each woman was selected only after the previously assigned woman had completed and exited the outpatient clinic.
Study limitations
* Infertility is emotionally sensitive; participants may withdraw or avoid discussing their feelings, affecting data completeness. This overcomes by ensure privacy during data collection. Train researchers in empathetic communication. Provide the option to skip questions that feel uncomfortable. Offer counseling referrals if needed.
* Women differ in duration of infertility, previous treatments, and cultural beliefs-these can influence psychological status. This overcomes by using statistical controls (e.g., covariates) to manage confounding variables. Clearly define inclusion/exclusion criteria.
* Participants in the control group may unintentionally receive information or support similar to the intervention group. This overcomes by scheduling sessions separately, using different staff for intervention vs. control groups. Keep materials inaccessible to the control group during the study.
* Participants may skip some sessions due to clinic schedules, stress, or treatment commitments. Offering flexible session times, reminders (phone, SMS), shorten sessions or offer hybrid formats (in-person + online) are solutions to overcoming this issue.
Despite of recent data on infertility globally are lacking, it has been estimated that 48 million couples and 186 million individuals worldwide live with infertility. Additionally, 12% of Egyptian couples have infertility, according to research by the Egyptian Fertility Care Society that was funded by the World Health Organization (WHO). 7.7% of them experience secondary infertility, while 4.3% experience main infertility.
Through the application of Levine's Conservation Model, the study highlights the vital role of nurses in promoting holistic adaptation and resilience during infertility treatment. Moreover, the outcomes can inform policy development and clinical guidelines that prioritize comprehensive, patient-centered care, thereby ensuring that infertile women receive not only medical treatment but also the emotional and social support necessary to thrive.
Aim The present study aims to evaluate the effect of nursing care based on Levine's Conservation Model on psychological adaptation, perception and perceived social support in infertile women. Research Hypotheses
1. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher perception scores post-intervention than women who receive routine care.
2. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher psychological adaptation scores post-intervention than women who receive routine care.
3. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher social support scores post-intervention than women who receive routine care.
Method Research Design A randomized controlled trial (RCT) research design was employed to examine the effect of nursing care based on Levine's Conservation Model on perception, psychological adaptation, and perceived social support among infertile women undergoing infertility treatment. This design was chosen because it is the most rigorous method of determining whether a cause-effect relationship exists between an intervention and outcome.
Study Setting The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University, that allocated in Menoufia Governorate, Egypt. It is a specialized outpatient clinic that provides diagnostic and therapeutic services for couples experiencing infertility. The setting was selected because it attracts a large number of women with primary and secondary infertility, thus providing an adequate sampling frame for the research studies.
A purposive sample of 80 diagnosed infertile women was selected from outpatient clinic according to the inclusion criteria. Each woman was allocated to either the intervention or control group through a coin toss conducted by the researcher. Due to some women are dropped out, recruitment continued until both groups reached the required sample size. If the coin toss directed a new woman to a group that had already reached its target number, that woman was not enrolled, and the researcher continued tossing the coin until a woman was assigned to the group that still needed members. This procedure was repeated until the intended number for both groups was fulfilled. They were divided into two equal groups: Group I (experimental group), composed of 40 women, educational conservation nursing intervention in addition to their medication regimen, while group II (control group), composed of 40 women received their medication regimen only. To avoid contamination between groups, each woman was selected only after the previously assigned woman had completed and exited the outpatient clinic.
Study limitations
* Infertility is emotionally sensitive; participants may withdraw or avoid discussing their feelings, affecting data completeness. This overcomes by ensure privacy during data collection. Train researchers in empathetic communication. Provide the option to skip questions that feel uncomfortable. Offer counseling referrals if needed.
* Women differ in duration of infertility, previous treatments, and cultural beliefs-these can influence psychological status. This overcomes by using statistical controls (e.g., covariates) to manage confounding variables. Clearly define inclusion/exclusion criteria.
* Participants in the control group may unintentionally receive information or support similar to the intervention group. This overcomes by scheduling sessions separately, using different staff for intervention vs. control groups. Keep materials inaccessible to the control group during the study.
* Participants may skip some sessions due to clinic schedules, stress, or treatment commitments. Offering flexible session times, reminders (phone, SMS), shorten sessions or offer hybrid formats (in-person + online) are solutions to overcoming this issue.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: