Levine's Conservation Model-Based Nursing Care

NCT07459894 | Completed DMC

• 1 other identifier: Study approved with No. 996
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Levin's conservative model; Psychological adaptation; Social support; Perception of infertility; Nursing care

Outcome Measures

Primary Outcomes (1)

• Psychological adaptation

  Psychological adaptation tool included the following two scales: I. 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. II. 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.

  This outcome was measured a baseline data, then it was again measured after two months of the intervention.

Secondary Outcomes (2)

• The infertility perception

  This outcome was measured a baseline data, then it was again measured after two months of the intervention.

• Social Support

  This outcome was measured a baseline data, then it was again measured after two months of the intervention.

Study Arms (2)

The first arm was called the experimental group

EXPERIMENTAL

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.

Behavioral: Levin's conservative model- based nursing care

The second arm was called the control group.

NO INTERVENTION

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

Levin's conservative model- based nursing care BEHAVIORAL

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.

The first arm was called the experimental group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 20-44 years
• Diagnosis of secondary infertility
• Undergoing fertility treatment regimen
• Willing to participate in the study.

You may not qualify if:

• Diagnosis of systemic and chronic diseases
• Diagnosis of cognitive impairments according to patients' file or record

Sponsors & Collaborators

• Fayoum University: lead
• Menoufia University: collaborator

Study Sites (1)

The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University

Shibīn al Kawm, Menoufia Governorate, 32511, Egypt

Location

Related Publications (10)

• Sharma A, Shrivastava D. (2022 ). Psychological Problems Related to Infertility. Cureus. Oct 15;14(10):e30320.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• Zegers-Hochschild, F., et al. (2021). International Committee for Monitoring Assisted Reproductive Technologies (ICMART) consensus on infertility care. Human Reproduction, 36(1), 1-12.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 5- Levine, M. E. (2020). The Conservation Model: A framework for nursing practice (Updated edition). Nursing Science Quarterly, 33(4), 356-362.

  BACKGROUND

• 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.

  BACKGROUND

• Boivin, J., & Gameiro, S. (2020). Evolution of psychology and counseling in infertility. Fertility and Sterility, 113(3), 563-565.

  BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Rasha Kamal Sweelam, Professor

  Menoufia University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start: April 15, 2025
• Primary Completion: July 3, 2025
• Study Completion: December 25, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)