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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological adaptation', 'timeFrame': 'This outcome was measured a baseline data, then it was again measured after two months of the intervention.', 'description': 'Psychological adaptation tool included the following two scales:\n\nI. Infertility psychological distress scale (Jiang et al., 2025): The IPDS provides a novel and reliable tool for assessing the infertility psychological distress of women undergoing ART. It consists of 25 items across 2 dimensions: Distress of disrupting the former self and Distress linked to the struggling present self.\n\nII. Fertility Adjustment Scale (FAS) (Glover et al., 1999): it can be used to assess the psychological reactions to fertility problems and outcomes of treatment. Participants were asked to rate their agreement or disagreement with each statement using a scale that ranged from 1 = strongly disagree to 6 = strongly agree. The minimum possible score was 12 and the maximum score was 72.'}], 'secondaryOutcomes': [{'measure': 'The infertility perception', 'timeFrame': 'This outcome was measured a baseline data, then it was again measured after two months of the intervention.', 'description': 'This outcome was measures using the infertility perception scale for women (IPS-W): (Ban Kim2024) This scale reflects the perception of infertility among women who are experiencing infertility and their spouse, family, and friends .It consists of a 4-point Likert scale with 21 items under four factors \\[ Factor-1 was named "perceived feelings," consisting of six items, Fac¬tor-2 was named "personal stigma," consisting of eight items, Factor-3 was named "social stigma," consisting of three items, and Factor-4 was named "acceptance," consisting of four items . The scale has a score range of 21-84 points, with higher scores indicating more negative perception.'}, {'measure': 'Social Support', 'timeFrame': 'This outcome was measured a baseline data, then it was again measured after two months of the intervention.', 'description': "This outcome was measured using The Multidimensional Scale of Perceived Social Support (MSPSS) is a widely used self-report instrument designed to assess an individual's perceived adequacy of social support from three distinct sources: family, friends, and a significant other. The scale consists of 12 items, divided into three subscales: family support, friends support, and significant other support. Each subscale contains 4 items, allowing both subscale scores and a total social support score to be calculated. The Items are rated on a 7-point Likert scale, ranging from (1 = Very strongly disagree) to (7 = Very strongly agree). Higher scores indicate greater perceived social support."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Levin's conservative model", 'Psychological adaptation', 'Social support', 'Perception of infertility', 'Nursing care'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Sharma A, Shrivastava D. (2022 ). Psychological Problems Related to Infertility. Cureus. Oct 15;14(10):e30320.'}, {'type': 'BACKGROUND', 'citation': 'Ramadan S& Said A. (2018) Effect of an Educational Intervention for Infertile Women Regarding Natural Fertility Methods and Sexual Skills for Improving Sexual Function. American Journal of Nursing Research, Vol. 6, No. 1, 1-11'}, {'type': 'BACKGROUND', 'citation': 'Hussein M. 2024. Environmental Risk Factors for Infertility Focusing on Egypt: A Narrative Review. Journal of High Institute of Public Health;54(1):40-47'}, {'type': 'BACKGROUND', 'citation': 'Moura-Ramos, M., & Gameiro, S. (2021). Role of psychosocial interventions in infertility care: A systematic review. Current Opinion in Obstetrics & Gynecology, 33(3), 158-164.'}, {'type': 'BACKGROUND', 'citation': 'Zegers-Hochschild, F., et al. (2021). International Committee for Monitoring Assisted Reproductive Technologies (ICMART) consensus on infertility care. Human Reproduction, 36(1), 1-12.'}, {'type': 'BACKGROUND', 'citation': "Özcan, H., & Kirca, N. (2023). Nursing care based on Levine's model improves psychological well-being in infertile women undergoing ART. Journal of Advanced Nursing, 79(5), 2111-2121."}, {'type': 'BACKGROUND', 'citation': "Saini NK, Kalia R. (2019). Levine's Conservation Model of Health. Asian J. Nursing Education and Research.; 9(3):466-468. DOI: 10.5958/2349-2996.2019.00097.1"}, {'type': 'BACKGROUND', 'citation': '5- Levine, M. E. (2020). The Conservation Model: A framework for nursing practice (Updated edition). Nursing Science Quarterly, 33(4), 356-362.'}, {'type': 'BACKGROUND', 'citation': 'Gurunath, S., Pandian, Z., Anderson, R. A., & Bhattacharya, S. (2022). Defining infertility: A systematic review of prevalence studies. Human Reproduction Update, 28(2), 137-148.'}, {'type': 'BACKGROUND', 'citation': 'Boivin, J., & Gameiro, S. (2020). Evolution of psychology and counseling in infertility. Fertility and Sterility, 113(3), 563-565.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nDespite 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.\n\nThrough 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.\n\nAim 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\n\n1. 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.\n2. 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.\n3. 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.\n\nMethod 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.\n\nStudy 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.\n\nA 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.\n\nStudy limitations\n\n* 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.\n* 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.\n* 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.\n* 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 20-44 years\n* Diagnosis of secondary infertility\n* Undergoing fertility treatment regimen\n* Willing to participate in the study.\n\nExclusion Criteria:\n\n* Diagnosis of systemic and chronic diseases\n* Diagnosis of cognitive impairments according to patients' file or record"}, 'identificationModule': {'nctId': 'NCT07459894', 'briefTitle': "Levine's Conservation Model-Based Nursing Care", 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': "Levine's Conservation Model-Based Nursing Care: A Framework for Enhancing Psychological Adaptation, Perception, and Social Support in Infertile Women: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'Study approved with No. 996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The first arm was called the experimental group', 'description': "The first Arm: the study variables were measured before the implementation of Levin's conservative model-based nursing care in the experimental group then they were again assessed after the intervention in the experimental group.", 'interventionNames': ["Behavioral: Levin's conservative model- based nursing care"]}, {'type': 'NO_INTERVENTION', 'label': 'The second arm was called the control group.', 'description': "The second arm: The control group who didn't receive any intervention were assessed before and after the implementation of Levin's conservative model-based nursing care."}], 'interventions': [{'name': "Levin's conservative model- based nursing care", 'type': 'BEHAVIORAL', 'description': "The intervention was designed according to Levine's four conservation principles (energy, structural integrity, personal integrity, and social integrity). It consisted of weekly face-to-face educational sessions lasting 45-60 minutes over 7 consecutive weeks, delivered to the study group only (Group I). Sessions were interactive, employing lectures, discussion, role-playing, and multimedia aids. Participants received educational booklets to reinforce learning capabilities at their homes.", 'armGroupLabels': ['The first arm was called the experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia Governorate', 'country': 'Egypt', 'facility': 'The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'overallOfficials': [{'name': 'Rasha Kamal Sweelam, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Menoufia University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to ethical restrictions and absence of participant consent for data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menoufia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Hussien Ahmed Kotb', 'investigatorAffiliation': 'Fayoum University'}}}}