Gynecologic NursingNCT05344677
Shoulder Pain and Post Gynecologic Laparoscopic Recovery
A study testing Trendelenburg Position, Warm Pad Application and Deep Breathing Exercise in people with Gynecologic Nursing and Postoperative Pain, run by Alexandria University at 1 site in Egypt.
Trial summary
The present study aims to investigate the effect of postoperative trendelenburg position versus warm pad application and deep breathing technique on shoulder pain intensity and post gynaecologic laparoscopic recovery Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Nursing, Postoperative Pain
- What is being tested?
- Trendelenburg Position, Warm Pad Application and Deep Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18-70 years
- women who were scheduled for diagnostic or operative gynecological laparoscopic surgery for non-malignant pathologies (e.g., hysterectomy, ovarian cystectomy)
- Free from any Medical history of deep vein thrombosis,shoulder surgery and chronic shoulder pain.
Who cannot join
- women with any medical or gynecological risk factors such as, morbid obese (BMI > 45) and pelvic inflammatory disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Trendelenburg Position, Warm Pad Application and Deep Breathing Exercise on Shoulder Pain and Post Gynecologic Laparoscopic Recovery
The present study aims to investigate the effect of postoperative trendelenburg position versus warm pad application and deep breathing technique on shoulder pain intensity and post gynaecologic laparoscopic recovery
Read the detailed description
Laparoscopic gynecologic surgery has evolved from a limited surgical procedure used only for diagnostic purposes to a major surgical approach for treating a multitude of malignant and non-malignant pathologies. It is currently considered one of the most common surgical procedures performed by gynecologists. Laparoscopic surgery, has become widely recognized as a viable alternative to traditional laparotomy in treatment of different gynecologic diseases . The advantages of laparoscopic surgery over traditional laparotomy include a smaller surgical wound, less postoperative pain, a shorter hospital stay, faster recovery, and a better cosmetic result. However, post-laparoscopic shoulder pain (PLSP), is a prevalent complaint following laparoscopic surgery with an incidence as high as 80%. The pain can be severe and is usually relieved in 24-48h, but rarely persists for over 72h after surgery. It has also been found that PLSP is less responsive to treatment than incision and visceral pain.
The precise mechanism of post-laparoscopic shoulder pain remains unclear. Carbon dioxide accumulation and phrenic nerve irritation as a result of diaphragmatic stretching are the most accepted explanations. A number of techniques that are proposed to diminish shoulder pain as intraperitoneal instillation of local anesthetics, pulmonary recruitment maneuver, warm and humidified dioxide, low pressure pneumoperitoneum and intraperitoneal normal saline infusion. Unfortunately, these interventions have often found quite varied and sometimes even conflicting results regarding their effectiveness.
Optimal pain management is imperative for the success of immediate and long term rehabilitation. Therefore, relieving PLSP is a problem that can no longer be ignored. Effective pain control is best achieved through a combination of both pharmaceutical and non-pharmaceutical therapies. Non pharmacological methods increase women/Patient control of her feeling, improve the activity level and functional capacity and reduce dosage of analgesic drugs thus decreasing the side effects of treatment.
One of the popular non-pharmacological techniques is heat therapy, it is easy to use, inexpensive, require no prior practice, and have minimal side effects when used properly. In addition to being used for pain relief, heat is used to relieve chills or trembling, decrease joint stiffness, reduce muscle spasm, and increase connective tissue extensibility
Also, one of the recommended non-pharmacological actions is to use deep breathing relaxation techniques. The technique of breathing relaxation itself is an act of nursing care, which in this case the nurse teaches the patients how to do deep breathing techniques, slow breathing (hold inspiration to the maximum) and how to exhale slowly. In addition to reducing pain intensity, deep breathing relaxation techniques can also improve lung ventilation and increase blood oxygenation.
In addition, the trendelenburg position might decrease shoulder pain by reducing the mechanical pressure exerted by CO2 on the diaphragm and the upper abdominal muscles. CO2, known for its high solubility, would also be displaced to the pelvis that has a rich vasculature which in turn speeds up the resorption of pneumoperitoneum .However, evidence-based research is still needed in the area of pain relief after gynecologic laparoscopy and few studies have attempted to identify the effect of warm application and trendelenburg position versus deep breathing technique on PLSP. So, the purpose of this study is to determine the effect of postoperative trendelenburg position, warm application, and deep breathing exercise on shoulder pain
- Conditions
- Gynecologic Nursing, Postoperative Pain
- Being tested
- Trendelenburg Position, Warm Pad Application, Deep Breathing Exercise
- Keywords
- Shoulder Pain after Gynecologic Laparoscopic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg PositionOther
Group 1 (trendlenburg position group) in which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period.
Warm Pad ApplicationOther
- Group 2 (warm pad application group) in this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours.
Deep Breathing ExerciseBehavioural
- Group 3: (deep breathing group) the researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers.
| Study group | Role | What they receive |
|---|---|---|
| trendlenburg position group | Experimental | in which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period Receives: Other: Trendelenburg Position |
| warm pad application group | Experimental | in this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours. Receives: Other: Warm Pad Application |
| deep breathing group | Experimental | the researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers Receives: Behavioral: Deep Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NRS)
It will be used to assess the severity of shoulder pain. Women will be instructed to choose a number from 0 to 10 that best describes their current pain.
Measured: Pain intensity will be evaluated for all groups up to 24 hours postoperative
Postoperative Quality of Recovery scale(QoR40)Postoperative Quality of Recovery scale(QoR40)
This tool was originally developed by Myles (2000), it is used to measure quality of recovery. It is consisted of 40 items, the items are grouped according to various aspects (dimensions) of recovery: emotional state (9items), physical comfort (12items), psychological support (7items), physical independence (5 items), and pain (7items). Subjects' response to each item will vary according to a 5 point likert scale, it was scored for positive item as "1= none of the time, 2=some of the time, 3= usually,4=most of time, and 5=all of the time.
Measured: postoperative recovery will be evaluated for all groups up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 May 2022
- Primary completion30 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gynecologic NursingStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Taha, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344677
- Sponsor's protocol ID
- 1527122021
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23.
PubMed 23136538Sutchritpongsa P, Tossamartworakul M. Pulmonary Recruitment Maneuver for Reducing Postoperative Shoulder Pain Incidence After Laparoscopic Gynecologic Surgery: A Prospective Randomized Controlled Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S204. doi: 10.1016/j.jmig.2015.08.736. Epub 2015 Oct 15. No abstract available.
PubMed 27679045Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
PubMed 31996139
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Trendelenburg Position, Warm Pad Application and Deep Breathing Exercise on Shoulder Pain and Post Gynecologic Laparoscopic Recovery
- ClinicalTrials.gov ID
- NCT05344677
- Acronym / sponsor ID
- 1527122021
- Conditions
- Gynecologic Nursing, Postoperative Pain
- Keywords
- Shoulder Pain after Gynecologic Laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to investigate the effect of postoperative trendelenburg position versus warm pad application and deep breathing technique on shoulder pain intensity and post gynaecologic laparoscopic recovery
Detailed description
Laparoscopic gynecologic surgery has evolved from a limited surgical procedure used only for diagnostic purposes to a major surgical approach for treating a multitude of malignant and non-malignant pathologies. It is currently considered one of the most common surgical procedures performed by gynecologists. Laparoscopic surgery, has become widely recognized as a viable alternative to traditional laparotomy in treatment of different gynecologic diseases . The advantages of laparoscopic surgery over traditional laparotomy include a smaller surgical wound, less postoperative pain, a shorter hospital stay, faster recovery, and a better cosmetic result. However, post-laparoscopic shoulder pain (PLSP), is a prevalent complaint following laparoscopic surgery with an incidence as high as 80%. The pain can be severe and is usually relieved in 24-48h, but rarely persists for over 72h after surgery. It has also been found that PLSP is less responsive to treatment than incision and visceral pain.
The precise mechanism of post-laparoscopic shoulder pain remains unclear. Carbon dioxide accumulation and phrenic nerve irritation as a result of diaphragmatic stretching are the most accepted explanations. A number of techniques that are proposed to diminish shoulder pain as intraperitoneal instillation of local anesthetics, pulmonary recruitment maneuver, warm and humidified dioxide, low pressure pneumoperitoneum and intraperitoneal normal saline infusion. Unfortunately, these interventions have often found quite varied and sometimes even conflicting results regarding their effectiveness.
Optimal pain management is imperative for the success of immediate and long term rehabilitation. Therefore, relieving PLSP is a problem that can no longer be ignored. Effective pain control is best achieved through a combination of both pharmaceutical and non-pharmaceutical therapies. Non pharmacological methods increase women/Patient control of her feeling, improve the activity level and functional capacity and reduce dosage of analgesic drugs thus decreasing the side effects of treatment.
One of the popular non-pharmacological techniques is heat therapy, it is easy to use, inexpensive, require no prior practice, and have minimal side effects when used properly. In addition to being used for pain relief, heat is used to relieve chills or trembling, decrease joint stiffness, reduce muscle spasm, and increase connective tissue extensibility
Also, one of the recommended non-pharmacological actions is to use deep breathing relaxation techniques. The technique of breathing relaxation itself is an act of nursing care, which in this case the nurse teaches the patients how to do deep breathing techniques, slow breathing (hold inspiration to the maximum) and how to exhale slowly. In addition to reducing pain intensity, deep breathing relaxation techniques can also improve lung ventilation and increase blood oxygenation.
In addition, the trendelenburg position might decrease shoulder pain by reducing the mechanical pressure exerted by CO2 on the diaphragm and the upper abdominal muscles. CO2, known for its high solubility, would also be displaced to the pelvis that has a rich vasculature which in turn speeds up the resorption of pneumoperitoneum .However, evidence-based research is still needed in the area of pain relief after gynecologic laparoscopy and few studies have attempted to identify the effect of warm application and trendelenburg position versus deep breathing technique on PLSP. So, the purpose of this study is to determine the effect of postoperative trendelenburg position, warm application, and deep breathing exercise on shoulder pain
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| trendlenburg position group | Experimental | Other: Trendelenburg Positionin which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period |
| warm pad application group | Experimental | Other: Warm Pad Applicationin this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours. |
| deep breathing group | Experimental | Behavioral: Deep Breathing Exercisethe researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18-70 years
- women who were scheduled for diagnostic or operative gynecological laparoscopic surgery for non-malignant pathologies (e.g., hysterectomy, ovarian cystectomy)
- Free from any Medical history of deep vein thrombosis,shoulder surgery and chronic shoulder pain.
Key exclusion criteria (1 listed)
- women with any medical or gynecological risk factors such as, morbid obese (BMI > 45) and pelvic inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendelenburg PositionGroup 1 (trendlenburg position group) in which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period. | Other | trendlenburg position group |
| Warm Pad Application• Group 2 (warm pad application group) in this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours. | Other | warm pad application group |
| Deep Breathing Exercise• Group 3: (deep breathing group) the researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers. | Behavioural | deep breathing group |
Primary outcome
Numerical Pain Rating Scale (NRS)
Time frame: Pain intensity will be evaluated for all groups up to 24 hours postoperative
It will be used to assess the severity of shoulder pain. Women will be instructed to choose a number from 0 to 10 that best describes their current pain.
Postoperative Quality of Recovery scale(QoR40)Postoperative Quality of Recovery scale(QoR40)
Time frame: postoperative recovery will be evaluated for all groups up to 24 hours postoperative
This tool was originally developed by Myles (2000), it is used to measure quality of recovery. It is consisted of 40 items, the items are grouped according to various aspects (dimensions) of recovery: emotional state (9items), physical comfort (12items), psychological support (7items), physical independence (5 items), and pain (7items). Subjects' response to each item will vary according to a 5 point likert scale, it was scored for positive item as "1= none of the time, 2=some of the time, 3= usually,4=most of time, and 5=all of the time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 23136538Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23.
- Background: PubMed 27679045Sutchritpongsa P, Tossamartworakul M. Pulmonary Recruitment Maneuver for Reducing Postoperative Shoulder Pain Incidence After Laparoscopic Gynecologic Surgery: A Prospective Randomized Controlled Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S204. doi: 10.1016/j.jmig.2015.08.736. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 31996139Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Taha study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg Position, Warm Pad Application and Deep Breathing Exercise in people with Gynecologic Nursing and Postoperative Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NRS) (time frame: Pain intensity will be evaluated for all groups up to 24 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344677, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.